Irish pharmaceutical company Amryt Pharma said today that the European Commission had approved its Mycapssa drug in the European Union for the maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with octreotide or lanreotide.
The drug is already approved in the US for long-term maintenance treatment in acromegaly patients.
Acromegaly typically develops when a benign tumour of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems.
Amryt focuses on the development and commercialisation of treatments for orphan and rare diseases patients.
It said today the centralised marketing authorisation for the drug will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway.
The EC approval of Mycapssa is supported by efficacy and safety data from three Phase 3 studies in acromegaly patients, it added.
Dr Joe Wiley, the chief executive of Amryt Pharma, said the EC approval of Mycapssa is a significant development for acromegaly sufferers in Europe.
"Mycapssa will be the first and only oral somatostatin analog approved in the EU," he added.
This is the second approval Amryt Pharma has received from the European Commission this year.
In June, it announced the European Commission approval of Filsuvez in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients six months and older.
EB is a rare and distressing genetic skin disorder affecting young children and adults for which, until the approval of Filsuvez there had been no approved treatment in any market.
