FDA finally approves Amicus' Pompe disease combo

After several delays, the US Food and Drug Administration (FDA) has finally approved Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) for the treatment of late onset Pompe disease/LOPD.

The approval was granted to Amicus Therapeutics (Nasdaq: FOLD), whose shares closed down almost 8% at $11.86 yesterday, but saw a pre-market recovery of 6.1% to $12.58.

The Pombiliti + Opfolda combination treatment was approved by European Medicines Agency in June this year for adults with late-onset Pompe disease, and in the UK last month.