FDA extends review of Amicus muscle disorder therapy for second time (updated)

Amicus Therapeutics

28/10/2022 21:51

(Adds background, analysts' comment)
       Oct 28 (Reuters) - The U.S. Food and Drug Administration
on Friday extended for the second time its review of Amicus
Therapeutics Inc's  FOLD.O  experimental combination therapy to
treat a muscle disorder called Pompe disease.
    The agency blamed the delay on pandemic-related travel
restrictions that kept it from conducting a required
manufacturing site inspection before the decision was due. 
        Amicus had disclosed in a regulatory filing last month
that an inspection of its partner WuXi Biologics'  2269.HK 
manufacturing site in China had not been scheduled at the time. 
    Analysts from BTIG and Needham & Co said the extension will
likely delay the launch of the therapy, AT-GAA, by a quarter. 
        Shares of the drugmaker were down 3% at $10.1 in
extended trading.
  
        Amicus was seeking approval for the expanded use of its
drug migulstat, in combination with its lab-made protein
cipaglucosidase alfa, which together form AT-GAA. 
    The U.S. FDA had in May extended its review of both the
components, saying it needed more time to go through the data
submitted by the company. 
    Pompe disease is a rare genetic condition in which the body
is unable to break down the complex sugar glycogen, leading to a
buildup of the same, which causes muscular impairment. The
condition may also lead to heart failure in young patients.
    Amicus and partner Wuxi are the latest companies to have
their review extended by the FDA over COVID-related travel
curbs. China-based Beigene  6160.HK  and Hutchmed Ltd  0013.HK 
as well as U.S.-based Coherus BioSciences Inc  CHRS.O  saw
similar extensions earlier in the year.
 (Reporting by Khushi Mandowara and Bhanvi Satija in Bengaluru;
Editing by Sriraj Kalluvila and Devika Syamnath)
 ((Khushi.Mandowara@thomsonreuters.com))