Posted by Michael Wonder on 18 Dec 2022
Amicus Therapeutics receives positive CHMP opinion for Pombiliti (cipaglucosidase alfa) for late-onset Pompe disease
16 December 2022 - CHMP adopts positive opinion based upon complete review of all pre-clinical, clinical studies and CMC data.
Amicus Therapeutics today announced that the CHMP of the EMA adopted a positive opinion recommending marketing authorisation of cipaglucosidase alfa, a long-term enzyme replacement therapy used in combination with miglustat for adults with late-onset Pompe disease.
