- A committee of the European Medicines Agency (EMA) recommended that the orphan disease designation to Amryt's ( NASDAQ: AMYT ) Mycapssa to treat acromegaly in the EU is maintained.
- 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 EMA's Committee for Orphan Medicinal Products (COMP) adopted the positive opinion.
- "The COMP recommendation to maintain the orphan disease designation for Mycapssa confirms the significant benefit of Mycapssa over the currently available injectable forms of somatostatin analogues, which represents a significant development for acromegaly sufferers in Europe," said Amryt CEO Joe Wiley.
- In September, EMA's Committee for Medicinal Products for Human Use (CHMP) had recommended the approval of Mycapssa as a maintenance therapy for certain patients with acromegaly.
- The orphan drug status in the EU provides for incentives, including 10 years' of market exclusivity for the drug, if approved.
For further details see:
Amryt gets EMA panel nod for Mycapssa to retain orphan drug status in EU