Irish pharmaceutical company Amryt said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its Mycapssa drug for the treatment of acromegaly.
Acromegaly typically develops when a benign tumour of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems.
The drug is already approved in the US for long-term maintenance treatment in acromegaly patients.
Based on the recommendation a decision by the European Commission is expected on the Mycapssa application within 67 days.
Amryt focuses on the development and commercialisation of treatments for orphan and rare diseases patients.
It said the centralised marketing authorisation would be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway.
Dr Joe Wiley, CEO of Amryt Pharma, said the 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.
