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