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
Click here to read full press release/ article | Ref: Globe Newswire | Image: Medcity News
The post Sanofi’s Nexviazyme (avalglucosidase alfa-ngpt) Receives the US FDA’s Approval for the Treatment of Late-Onset Pompe Disease first appeared on PharmaShots.
