- A committee of the European Medicines Agency (EMA) recommended the approval of Amryt's ( NASDAQ: AMYT ) Mycapssa (octreotide capsules) in the EU as a maintenance therapy of acromegaly in patients who have responded to and tolerated treatment with octreotide or lanreotide.
- Acromegaly is a disorder characterized by the pituitary gland producing too much growth hormone during adulthood. The bones in the hands, feet and face become bigger.
- The decision of the EMA's Committee for Medicinal Products for Human Use (CHMP) was backed by data from a phase 3 trial called MPOWERED.
- The European Commission (EC), which generally follows the opinion of the CHMP, will now decide on the drug's approval.
- The EC decision is expected within within 67 days, the company said in a Sept. 16 press release.
- "The CHMP recommendation for approval of Mycapssa is a very significant development for acromegaly sufferers in Europe and Mycapssa would be the first and only oral somatostatin analog approved in the EU," said Amryt CEO Joe Wiley.
For further details see:
Amryt growth hormone disorder drug Mycapssa gets EMA panel nod for EU approval