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Sanofi's Nexviazyme (avalglucosidase alfa-ngpt) Receives the US FDA's Approval for the Treatment of Late-Onset Pompe Disease

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Sanofi's Nexviazyme (avalglucosidase alfa-ngpt) Receives the US FDA's Approval for the Treatment of Late-Onset Pompe Disease

Sanofi's Nexviazyme (avalglucosidase alfa-ngpt) Receives the US FDA's Approval for the Treatment of Late-Onset Pompe Disease

Shots:

  • The approval is based on the P-III COMET trial that evaluates Nexviazyme (q2w- IV infusion) vs alglucosidase alfa in patients aged ≥1yrs. with LOPD for 49wks.
  • Results: patients achieved noninferiority with 2.4 points greater improvement in FVC percent-predicted @49wks.- were able to walk 32.2 m farther @49wks. on the 6MWT. The therapy showed improvements in respiratory function and walking distance with a safety profile
  • Nexviazyme is an ERT targeting M6P receptor & previously received the FDA’s BTD & FTD for the treatment of PD. Additionally- the approval follows the FDA’s priority review granted in Nov’2018

Ref: Globe Newswire | Image: Medcity News

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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