- The FDA has accepted for review Amicus Therapeutics Inc’s (NASDAQ:FOLD) Biologics License Application (BLA) for cipaglucosidase alfa and the New Drug Application (NDA) for miglustat for AT-GAA.
- Also Read: Amicus’s Fabry Disease Medicine Gets European Approval For Use In Adolescents
- AT-GAA two-component therapy for Pompe disease inherited lysosomal disorder characterized by severe muscle weakness.
- AT-GAA consists of cipaglucosidase alfa (ATB200), a recombinant human acid alpha-glucosidase (rhGAA) enzyme administered in conjunction with miglustat (AT2221), a stabilizer of cipaglucosidase alfa.
- The agency’s PDUFA target action date for NDA is May 29, 2022, and July 29, 2022, for BLA.
- The Marketing Authorization Application for AT-GAA in Europe is expected to be submitted in Q4 of 2021.
- In June 2021, the U.K.’s Medicines and Healthcare Products Regulatory Agency granted AT-GAA a positive scientific opinion through the Early Access to Medicines Scheme.
- Related content: Benzinga’s Full FDA Calendar.
- Price Action: FOLD stock traded 19.40% higher at $12.16 premarket on the last check Wednesday.
ICER’s Report Suggests Benefits Of Eli Lilly’s Tirzepatide Not Better Than Other Diabetes Drugs
Institute for Clinical and Economic Review (ICER) casts doubts on Eli Lilly And Co’s (NYSE: LLY) tirzepatide, a type II diabetes candidate, about its usefulness to patients compared to the rivals.
