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Pompe

A short video raising awareness of Pompe disease

Pompe Disease Awareness

A short video raising awareness of Pompe disease

SPECIALTY-CARE

RARE-DISEASE

POMPE

&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.

<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.&nbsp;Nexviadyme should be used during breast-feeding only if the potential benefits to the mother outweigh the potential risks, including those to the breast-fed child.

<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.

<h2>Learn more about Nexviadyme®</h2>

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.

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

Get in touch with us

Abbreviations

<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 Prescribing Information UK

NEXVIAZYME

Nexviadyme®▼
(avalglucosidase alfa) safety profile

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

Nexviadyme®▼
(avalglucosidase alfa) evidence

<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

<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;

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.

<h2>Safety</h2>
In the COMET trial, there were fewer numerical 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

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

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

<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.

<a href="${link:{uuid:{cf1f3311-de33-48bd-a469-b9f8adafc603},repository:{dam},path:{/Portal/UK/Prescribing-links/Nexviadyme-PI-GB-November-2022-v2.pdf}}}" style="color: rgb(122 0 230) !important;">Nexviadyme ▼ (avalglucosidase alfa) prescribing information UK</a>

<h2>Details</h2>
Click below to enter the website for patients in Britain who have been prescribed Nexviadyme, or their caregiver.

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Nexviadyme®▼ (avalglucosidase alfa) safety profile

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Nexviadyme®▼ (avalglucosidase alfa) patient and caregiver website