Amicus announces FDA approval of Pombiliti plus Opfolda

Amicus Therapeutics announced that the U.S. Food and Drug Administration has approved Pombiliti + Opfolda 65mg capsules. This two-component therapy is indicated for adults living with late-onset Pompe disease weighing greater than or equal to 40 kg and who are not improving on their current enzyme replacement therapy, or ERT, the company stated. Amicus Therapeutics will launch Pombiliti + Opfolda immediately in the U.S. The FDA previously granted Breakthrough Therapy designation for Pombiliti + Opfolda. Pombiliti + Opfolda has also been approved for the treatment of adults with LOPD in the European Union and the United Kingdom, the company noted.