&nbsp;
This is intended for HCPs practising in Great Britain (England, Scotland and Wales) only.

Myozyme (alglucosidase alfa) Prescribing Information GB

Explore the results and evidence supporting Nexviadyme®&nbsp;and how it was studied through several clinical trials.

POMPE

RARE-DISEASE

Nexviadyme®▼
(avalglucosidase alfa) evidence

<h2>Explore Nexviadyme® trials</h2>

<h4>NEO1 
 (Phase 1)1</h4>
<a href="https://pro.campus.sanofi/uk/pompe/articles/nexviadyme-evidence#anchor2">Learn more</a>

<h4>NEO-EXT 
 (Phase 2)2</h4>
<a href="https://pro.campus.sanofi/uk/pompe/articles/nexviadyme-evidence#anchor3">Learn more</a>

<h4>COMET trial 
 (Phase 3)3</h4>
<a href="https://pro.campus.sanofi/uk/pompe/articles/nexviadyme-evidence#anchor1">Learn more</a>

<h4>Mini-COMET 
 trial4</h4>
<a href="https://pro.campus.sanofi/uk/pompe/articles/nexviadyme-evidence#anchor4">Learn more</a>

<h2>NEO1 (Phase 1)1</h2>
A multicentre, multinational, open-label, ascending dose study of Nexviadyme in ERT-experienced and -naïve patients with LOPD.

Outcomes

Key inclusion criteria

<h2>NEO-EXT (Phase 2)2</h2>
A multicentre, multinational, open-label study of Nexviadyme in ERT-experienced and -naïve patients with LOPD.

Key inclusion criteria

Download overview of NEO-EXT (pdf)

<h2>NEO1 (N=14) ERT-experienced5</h2>
Long-term treatment effect of Nexviadyme on FVC and 6MWT has been shown for up to 8 years in an uncontrolled open-label study in patients with LOPD (NEO1/NEO-EXT).5&nbsp;Each line represents an individual patient.

Adapted from Byrne BJ, et al. 2024.5&nbsp;

Adapted from Byrne BJ, et al. 2024.5&nbsp;

<h2>NEO1 (N=10) ERT-naïve5</h2>
Long-term treatment effect of Nexviadyme on FVC and 6MWT has been shown for up to 8 years in an uncontrolled open-label study in patients with LOPD (NEO1/NEO-EXT).5&nbsp;Each line represents an individual patient.

Adapted from Byrne BJ, et al. 2024.5

<h2>COMET trial (Phase 3)3</h2>
A multicentre, multinational, randomised, double-blinded study to compare the efficacy and safety of bi-weekly infusions of Nexviadyme and Myozyme in patients with LOPD.

*Screening phase up to 14 days, may be extended to up to 8 weeks in pre-specified situations&nbsp; 
 †Randomization 1:1 ratio with stratification factors based on Baseline forced vital capacity, sex, age, and country (Japan or ex-Japan)&nbsp; 
 ‡Study drug infusion, safety assessments, and efficacy evaluations&nbsp; 
 §All participants regardless of prior randomization

<h2>FVC (% predicted), primary endpoint6</h2>
LS mean improvement of 1.40% with Nexviadyme and 1.18% in switch arm participants at week 145 vs baseline (statistical significance not reported).6

Adapted from Kishnani PS, et al. 2023.6 
 *1 participant’s FVC % predicted value at Week 97 was excluded due to a physiologically implausible change between Weeks 73 &amp; 97 and 97 &amp; 121.

<h2>6MWT, secondary endpoint6</h2>
LS mean improvement in 6MWT of&nbsp; 20.65 m with Nexviadyme and 0.29 m in switch arm participants at week 145 vs baseline (statistical significance not reported).6

Adapted from Kishnani PS, et al. 2023.6

Baseline chemographics and characteristics3

Respiratory muscle strength data (secondary endpoints)

Strength and motor function data (secondary endpoints)

HRQoL data (secondary endpoints)

Hex4 data (exploratory pharmacodynamic marker)

<h2>Mini-COMET trial4</h2>
Of 22 included patients with IOPD (1 year of age of older, declining or with sub-optimal response on Myozyme), 16 received Nexviadyme and showed improvement or stabilisation based on secondary outcome measures of preliminary efficacy. The primary outcome measure of Mini-COMET was safety.
This was shown in Mini-COMET across cardiac function, motor function and mobility.8 
 &nbsp;

<h3>Cardiac function</h3>
Assessed by ECHO-LVM 
 z score

<h3>Motor function</h3>
Assessed by the GMFM-88 
 and QMFT

<h3>Mobility</h3>
Assessed by the Pompe- 
 PEDI

Patients showed stabilisation or improvement in the mobility domain of the Pompe-PEDI.8

Adapted fron Kronn D, et al. 2024.8 
 Patients are represented by separate lines, with the first dot representing the age at inclusion in the trial and last dot at conclusion for this trial period.
The Pompe-PEDI is based on caregiver reports.

Download overview of MINI-COMET (pdf)

<h2>Safety</h2>
In the COMET trial, there were fewer treatment-related SAEs and IARs with Nexviadyme than with Myozyme. During the 49-week primary analysis period, no patients withdrew from the Nexviadyme arm.3

<h2>Learn more about Nexviadyme®</h2>

Learn more about the safety and tolerability profile for Nexviadyme&reg;.

Read more about treatment with Nexviadyme&reg; for patients living with Pompe disease.

Do you have questions or need support? We are here to help you.

Get in touch with us

<h3>Overview of Neo-EXT 
 &nbsp;</h3>

Abbreviations

<h4>References</h4>
<ol>
 <li>
 Pena LDM, et al. Safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of the novel enzyme replacement therapy avalalucosidase alfa (neoGAA) in treatment-naive and alglucosidase alfa-treated patients with late-onset Pompe disease: A phase 1, open-label, multicenter, multinational, ascending dose study. Neuromuscul Disord. 2019 Mar;29(3):167-186.</li>
 <li>
 Dimachkie MM, et al. Long-term Safety and Efficacy of Avalglucosidase Alfa in Patients With Late-Onset Pompe Disease. Neurology. 2022 May 26;99(5):e536-48.</li>
 <li>
 Diaz-Manera J, et al. Safety and efficacy of avalglucosidase alfa versus alglucosidase alfa in patients with late-onset Pompe disease (COMET): a phase 3, randomised, multicentre trial. Lancet Neural. 2021 Dec;20(12):1012-1026.</li>
 <li>
 Kishnani PS, et al. Safety and efficacy of avalglucosidase alfa in individuals with infantile-onset Pompe disease enrolled in the phase 2, open-label Mini­ COMET study: The 6-month primary analysis report. Genet Med. 2023 Feb;25(2):100328. Epub 2022 Dec 21.</li>
 <li>
 Byrne BJ, et al. NEO1/NEO-EXT Studies: Long-Term Muscle Quantitative Magnetic Resonance Imaging and Functional Efficacy in Adults With Late-Onset Pompe Disease (LOPD) on Avalglucosidase Alfa Treatment. Poster presented at the 20th Annual WORLDSymposium 2024, February 4 -9, 2024, San Diego, CA, USA.&nbsp;</li>
 <li>
 Kishnani PS, et al. Efficacy and Safety of Avalglucosidase Alfa in Participants With Late-Onset Pompe Disease After 145 Weeks' Treatment During the COMET Trial. ePoster presented in Orlando, Florida, USA, February 22 -26, 2023.&nbsp;</li>
 <li>
 Kishnani PS, et al. COMET Investigator Group. Efficacy and Safety of Avalglucosidase Alfa in Patients With Late-Onset Pompe Disease After 97 Weeks: A Phase 3 Randomized Clinical Trial. JAMA Neurol. 2023 Jun 1;80(6):558-567. doi: 10.1001/jamaneurol.2023.0552.</li>
 <li>
 Kronn D, et al. Mini-COMET Study: Safety and Efficacy Data After Avalglucosidase Alfa Dosing for ≥145 Weeks in Participants With Infantile-Onset Pompe Disease (IOPD) Who Had Demonstrated Clinical Decline or Sub-Optimal Response Whilst Receiving Alglucosidase Alfa. Encore poster presented at the 20th Annual WORLDSymposium 2024, February 4 -9, 2024, San Diego, CA, USA.</li>
 <li>
 Sanofi. Nexviadyme (avalglucosidase alfa). Summary of Product Characteristics. 2024. Available at: https://www.medicines.org.uk/emc/product/14562/smpc#gref.</li>
</ol>

Explore the results and evidence supporting Nexviadyme® and how it was studied through several clinical trials.

Nexviadyme Prescribing Information GB

&nbsp;
The safety of Nexviadyme® has been studied in patients older than 6 months of age acrosss both LOPD and IOPD1
<h2>Summary of safety information</h2>
Please refer to the <a href="https://www.medicines.org.uk/emc/product/14562/smpc#gref" target="_blank">Summary of Product Characteristics</a> before prescribing.

<h4>Dosage and Administration</h4>
Nexviadyme® treatment should be supervised by a physician experienced in the management of patients with Pompe disease or other inherited metabolic or neuromuscular diseases. Patients may be pretreated with antihistamines, antipyretics and/or corticosteroids to prevent or reduce allergic reactions. 
 The recommended dose of avalglucosidase alfa is 20 mg/kg of body weight administered once every 2 weeks. Nexviadyme vials are for single use only and the medicinal product should be administered as an intravenous infusion. The infusion should be administered incrementally as determined by patient response and comfort; refer to the SmPC for the infusion rate schedule.

<h4>Dose modification for IOPD patients</h4>
For IOPD patients who experience lack of improvement or insufficient response in cardiac, respiratory, and/or motor function while receiving 20 mg/kg, a dose increase to 40 mg/kg every other week should be considered in the absence of safety concerns (e.g., severe hypersensitivity, anaphylactic reactions, or risk of fluid overload). In patients who do not tolerate avalglucosidase alfa at 40 mg/kg every other week (e.g., severe hypersensitivity, anaphylactic reactions, or risk of fluid overload), consider decreasing the dose to 20 mg/kg every other week.

<h2>Special Populations</h2>
Click below to learn more about Nexviadyme® safety for special populations.

Elderly patients

Hepatic impairment

Renal impairment

Paediatric population (patients 6 months of age and younger)

<h2>Contraindications</h2>
Life-threatening hypersensitivity to the active substance or to any of the excipients listed in the SmPC.
<h2>Precautions and Warnings</h2>
Hypersensitivity reactions (including anaphylaxis)
Hypersensitivity reactions, including anaphylaxis, have been reported in Nexviadyme-treated patients. Appropriate medical support measures, including cardiopulmonary resuscitation equipment especially for patients with cardiac hypertrophy and patients with significantly compromised respiratory function, should be readily available when Nexviadyme is administered. If severe hypersensitivity or anaphylaxis occur, Nexviadyme should be discontinued immediately, and appropriate medical treatment should be initiated. The risks and benefits of re-administering Nexviadyme following anaphylaxis or severe hypersensitivity reaction should be considered.
IARs
In clinical studies, IARs were reported to occur at any time during and/or within a few hours after the infusion of Nexviadyme and were more likely with higher infusion rates. Patients with an acute underlying illness at the time of Nexviadyme infusion appear to be at greater risk for IARs. Patients with advanced Pompe disease may have compromised cardiac and respiratory function, which may predispose them to a higher risk of severe complications from IARs. If severe IARs occur, immediate discontinuation of the administration of Nexviadyme should be considered and appropriate medical treatment should be initiated. The benefits and risks of readministering Nexviadyme following severe IARs should be considered.
Immunogenicity
Treatment emergent ADA were reported in both treatment naïve and treatment experienced patients. Adverse-event-driven immunologic testing, including IgG and IgE ADA, may be considered for patients who have risk for allergic reaction or previous anaphylactic reaction to alglucosidase alfa.
Risk of acute cardiorespiratory failure
Caution should be exercised when administering Nexviadyme to patients susceptible to fluid volume overload or patients with acute underlying respiratory illness or compromised cardiac and/or respiratory function for whom fluid restriction is indicated. These patients may be at risk of serious exacerbation of their cardiac or respiratory status during infusion. Appropriate medical support and monitoring measures should be readily available during Nexviadyme infusion.
Cardiac arrhythmia and sudden death during general anaesthesia for central venous catheter placement
Cardiac arrhythmia, including ventricular fibrillation, ventricular tachycardia, and bradycardia, resulting in cardiac arrest or death, or requiring cardiac resuscitation or defibrillation, have been associated with the use of general anaesthesia in IOPD patients with cardiac hypertrophy.
Interactions
No interaction studies have been performed. Because it is a recombinant human protein, avalglucosidase alfa is an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Fertility and Lactation
There are no available data on the use of Nexviadyme in pregnant women. The potential risk for humans is unknown. Nexviadyme should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the foetus.&nbsp;
Breast-feeding
There are no available data on the presence of Nexviadyme in human milk or the effects of Nexviadyme on milk production or the breastfed infant.

<h2>Adverse reactions</h2>
Very common (≥1/10)
Hypersensitivity, headache, nausea, pruritus and rash.
Common (≥1/100 to &lt;1/10)
Anaphylaxis,&nbsp; dizziness, tremor, somnolence, burning sensation, ocular hyperaemia, conjunctival hyperaemia, eye pruritus, eyelid oedema, tachycardia, flushing, hypertension, hypotension, cyanosis, hot flush, pallor, cough, dyspnoea, respiratory distress, throat irritation, oropharyngeal pain, diarrhoea, vomiting, lip swelling, swollen tongue, abdominal pain, abdominal pain upper, dyspepsia,&nbsp; urticaria, erythema, palmer erythema, hyperhidrosis, rash erythematous, rash pruritic, skin plaque, muscle spasms, myalgia, pain in extremity, flank pain, fatigue, chills, chest discomfort, pain, influenza like illness, infusion site pain, pyrexia, asthenia, face oedema, feeling cold, feeling hot, sluggishness, blood pressure increased, oxygen saturation decreased and body temperature increase.&nbsp;
Prescribers should consult the <a href="https://www.medicines.org.uk/emc/product/14562/smpc#gref" target="_blank">SmPC</a> in relation to other adverse reactions.

Explore the results and evidence supporting Nexviadyme&reg; and how it was studied through several clinical trials.

Read more about treatment with Nexviadyme&reg; (avalglucosidase alfa) for patients living with Pompe disease.

<h4>References</h4>
<ol>
 <li>
 Sanofi. Nexviadyme (avalglucosidase alfa). Summary of Product Characteristics. 2024. Available at: <a href="https://www.medicines.org.uk/emc/product/14562/smpc#gref" target="_blank">https://www.medicines.org.uk/emc/product/14562/smpc#gref</a>.</li>
</ol>

Find out more about the safety and tolerability profile for Nexviadyme®.

Nexviadyme®▼
(avalglucosidase alfa) safety profile

<h2>Treatment</h2>
<h3>Pompe disease can be treated using enzyme replacement therapy (ERT).</h3>

<h2>Specialist Treatment Centres</h2>
There are experts throughout the UK who can provide the best care and treatment for patients with Pompe metabolic and neuromuscular
These are shown below:

<a href="${link:{uuid:{929a08d4-6daf-434b-aea1-9932473e22a9},repository:{products},path:{/UK/myozyme}}}" target="_self">Find out more about treatment for Pompe disease</a>

Treatment and Specialist Treatment Centres in the UK for Pompe disease

<h2>About Pompe disease</h2>
Pompe disease most commonly affects the respiratory and musculoskeletal muscles.1 Patients with Pompe disease will usually present with a broad spectrum of clinical phenotypes at different ages:2

<ul>
 <li>
 As infants, also known as infantile-onset Pompe disease (IOPD)</li>
 <li>
 As children and adults, which is also known as late-onset Pompe disease (LOPD)</li>
</ul>

Pompe disease is also known as: acid maltase deficiency or glycogen storage type II disease (GSD II).1
Pompe disease is a life-limiting, progressive neuromuscular disorder caused by an inherited deficiency of enzyme activity leading to irreversible muscle damage1,2,5,6&nbsp;– but enzyme replacement therapy is available7

Illustration based on Thurberg,&nbsp;et al. 2006.4

Signs and Symptoms of Pompe disease

<h2>Epidemiology</h2>
Incidence estimates for Pompe disease range from 1 in 33,333 to 1 in 138,0008-9. However, it is difficult to know exactly how many people are actually affected.
It is estimated that the current worldwide prevalence may be 1 in 57000.10

Why test early for Pompe disease?

<h2>Genetics and inheritance</h2>
A gene located on chromosome 17 encodes for the production of acid alpha-glucosidase (GAA), the enzyme responsible for breaking down glycogen to glucose inside lysosomes.12&nbsp;A genetic mutation within this gene causes a deficiency, or complete absence, of GAA enzyme which results in intra-lysosomal accumulation of glycogen, primarily in muscle cells.13&nbsp;Pompe disease is an inherited autosomal recessive disease: two faulty genes must be inherited from both parents for the person to develop Pompe disease.14
At 1 in 57,000 people10&nbsp;there are estimated to be other 1,000 people with Pompe in the UK alone.

Testing and Diagnosis of Pompe disease

Pompe disease (glycogen storage type II disease) is caused by a deficiency of acid alphaglucosidase (GAA) enzyme activity, resulting in lysosomal glycogen accumulation in muscles and irreversible muscle damage.1-3

What is Pompe disease?

This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only.
Watch the video below to find out how our 30-year commitment to rare disease1&nbsp;means we always lead with science, and put patients, their families, and the community at the centre of everything we do.&nbsp;

Our commitment to rare disease 

Nexviadyme®&nbsp;▼(avalglucosidase alfa) prescribing information GB

Myozyme® (alglucosidase alfa) prescribing information GB

From the challenges of cell delivery, to optimising targeting,2,4&nbsp;explore why Sanofi developed Nexviadyme&reg;.

Watch how we used preclinical mice models of Pompe to design Nexviadyme&reg;, and improve maintenance of muscle strength compared to Myozyme&reg;.3,5

Nexviadyme® ▼ (avalglucosidase alfa) prescribing information GB

Myozyme® (alglucosidase alfa) prescribing information GB

Myozyme® (alglucosidase alfa) prescribing information NI

This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only.
This video outlines the development process for Nexviadyme®. Find out how we used preclinical mice models of Pompe to help design Nexviadyme®, and ultimately, improve maintenance of muscle strength compared to Myozyme®.1,2

Watch the below video to find out how we developed Nexviadyme® to ultimately try to improve outcomes for patients with Pompe disease.

How Nexviadyme®▼ (avalglucosidase alfa) was designed

Nexviadyme® (avalglucosidase alfa) prescribing information GB

Find out how we have led with science for over 30 years,3&nbsp;and continue to bring innovation to people living with lysosomal storage disorders.

Watch the below video to find out how we developed Nexviadyme® to ultimately try to improve outcomes for patients with Pompe disease.

Nexviadyme®▼(avalglucosidase alfa) prescribing information GB

This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only.
In this video, find out how we used glycoengineering and chemical conjugation to help overcome the challenge of cellular delivery of acid alpha-glucosidase, by increasing the levels of bis-M6P1,4&nbsp;compared to Myozyme (alglucosidase alfa).

Why we developed Nexviadyme®▼ (avalglucosidase alfa)

Find out how we have led with science for over 30 years,5&nbsp;and continue to bring innovation to people living with lysosomal storage disorders.

Watch how we used preclinical mice models of Pompe to design Nexviadyme&reg;, and improve maintenance of muscle strength compared to Myozyme&reg;.1,3

 Nexviadyme®▼(avalglucosidase alfa) prescribing information GB

<h2>Testing</h2>
<h3>Start with a simple, reliable blood-based test</h3>
GAA assays using whole blood or dried blood spot (DBS) samples are an established diagnostic method for Pompe disease.1,2 &nbsp;
Muscle biopsy is less reliable than a blood-based test for Pompe disease because it can miss more than one third (37%) of positive diagnoses.2-4

Acid alpha-glucosidase activity assay is the gold standard for Pompe disease diagnosis.5

<table border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
 <tr>
 <td>
 <h3>Why not rule out Pompe disease early by incorporating a blood-based assay in your differential diagnosis?</h3></td>
 </tr>
 </tbody>
</table>

<h3>Other tests to consider include:</h3>
<ul>
 <li>Biopsies (skin and muscle), although these can be invasive for the patient and potentially inconclusive6,7&nbsp;</li>
 <li>Genetic testing</li>
 <li>Next Generation Sequencing (NGS), which can be used to quickly analyse a person’s genome to determine a diagnosis8</li>
</ul>

<h2>Diagnosis</h2>
Diagnosing Pompe disease can be challenging due to:

Unlike other neuromuscular disorders, respiratory symptoms are often one of the first clinical manifestations of Pompe disease, and may precede proximal muscle weakness11,12&nbsp;
Pompe disease shares similar signs and symptoms with a number of the other conditions and should be considered as part of the differential diagnosis for all children and adults presenting with limb-girdle weakness and/or respiratory insufficiency.3

<table border="1" cellpadding="20" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(82, 92, 163); width: 70%;">
 Patient Presentation/Symptoms&nbsp;</td>
 <td style="background-color: rgb(82, 92, 163);">
 # of patients&nbsp;</td>
 <td style="background-color: rgb(82, 92, 163);">
 % with Pompe Disease&nbsp;</td>
 </tr>
 <tr>
 <td style="background-color: rgb(230, 237, 249); width: 70%;">
 Undefined limb-girdle myopathy or undiagnosed proximal muscle weakness (2013)13&nbsp;</td>
 <td style="background-color: rgb(230, 237, 249);">
 144&nbsp;</td>
 <td style="background-color: rgb(230, 237, 249);">
 10.2%&nbsp;</td>
 </tr>
 <tr>
 <td style="background-color: rgb(230, 237, 249); width: 70%;">
 Unclassified limb-girdle muscular dystrophy (2013)14</td>
 <td style="background-color: rgb(230, 237, 249);">
 38</td>
 <td style="background-color: rgb(230, 237, 249);">
 8.0%</td>
 </tr>
 <tr>
 <td style="background-color: rgb(230, 237, 249); width: 70%;">
 Idiopathic hyperCKemia or newly presenting patients with hyperCKemia (2013)13</td>
 <td style="background-color: rgb(230, 237, 249);">
 207</td>
 <td style="background-color: rgb(230, 237, 249);">
 2.4%</td>
 </tr>
 <tr>
 <td style="background-color: rgb(230, 237, 249); width: 70%;">
 Asymptomatic hyperCKemia of unknown cause (2013)16</td>
 <td style="background-color: rgb(230, 237, 249);">
 137</td>
 <td style="background-color: rgb(230, 237, 249);">
 1(0.9)%</td>
 </tr>
 <tr>
 <td style="background-color: rgb(230, 237, 249); width: 70%;">
 HyperCKemia and no clinical muscle weakness (2006)17</td>
 <td style="background-color: rgb(230, 237, 249);">
 104</td>
 <td style="background-color: rgb(230, 237, 249);">
 3.8%</td>
 </tr>
 </tbody>
</table>

Testing and Diagnosis of Pompe disease

Patients with Pompe disease often face delayed diagnosis, it should be considered when signs and symptoms suggest progressive muscular degeneration in infants, children, adolescents and adults18,19
The ability to correctly differentiate Pompe disease from other disorders is crucial for minimising diagnostic delays and optimising patient outcomes and the earlier a patient receives treatment, the better their long-term prognosis.

<h3>Delayed diagnosis can lead to significant muscle tissue deterioration21, diminished physical function, and premature death3,18,19,20</h3>
<h3>Due to the overlapping symptoms of Pompe disease and other neuromuscular conditions, consider re-examining some patients to rule out Pompe disease, including those with:&nbsp;</h3>
<ul>
 <li>Unspecified limb-girdle myopathies13-15&nbsp;</li>
 <li>Unexplained respiratory problems22</li>
 <li>Unexplained skeletal muscle problems22</li>
 <li>Patients with hyperCKemia13,16,17</li>
</ul>

In a prospective cohort screening study of 3,076 patients tested with dried blood spot, 74 patients were diagnosed with Pompe disease. From this study, 2.4% of patients with unclassified limb-girdle muscle weakness was found to be Pomep disease. It was therefore concluded that when patients present with limb-girdle muscle weakness routine testing for Pompe disease should occur.23

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MAT-XU-2300297 (v6.0) - Date of Preparation: April 2024

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