The EC approval of Mycapssa is backed by efficacy and safety data from three phase 3 studies in acromegaly patients, which include the MPOWERED trial
Amryt secures EC approval for Mycapssa for acromegaly. (Credit: EmDee/Wikimedia Commons)
Ireland-based Amryt has received approval from the European Commission (EC) for its oral somatostatin analogue Mycapssa as a maintenance therapy for patients with acromegaly who responded to and tolerated treatment with lanreotide or octreotide.
The biopharma company can market the drug in all member states of the European Union (EU) as well as in Iceland, Norway, and Liechtenstein.
Amryt Pharma CEO Joe Wiley said: “The EC approval of Mycapssa is a significant development for acromegaly sufferers in Europe and Mycapssa will be the first and only oral somatostatin analog approved in the EU.”
The European Commission’s approval of Mycapssa is backed by efficacy and safety data from three phase 3 studies involving acromegaly patients. These include the MPOWERED trial.
In the MPOWERED study, the primary non-inferiority endpoint was met and 91% of patients on Mycapssa maintained insulin-like growth factor 1 response throughout the randomised controlled treatment (RCT), compared to patients who were fully on injectable somatostatin receptor ligands (iSRLs).
The MPOWERED trial was a 15-month global, randomised, open-label and active-controlled trial undertaken for supporting approval of the somatostatin analogue in the EU.
A total of 146 adult acromegaly patients were enrolled in the study of which 92 who were deemed to respond to octreotide capsules following a six-month run-in were randomised to receive either octreotide capsules or injectable somatostatin receptor ligands (iSRLs).
Additionally, another phase 3 study showed a statistically significant improvement in symptoms at the end of treatment with Mycapssa, compared to when subjects were treated with injectable somatostatin analogues.
Mycapssa has approval in the US for long-term maintenance treatment in patients with acromegaly who have responded to and tolerated treatment with injectable octreotide or lanreotide.