Marvellous news from Amryt Pharma plc (AMYT ) today with its FDA approved Acromegaly tablet Mycapssa meeting its primary endpoint goal in a new The Lancet published Phase 3 trial.
That being to assess whether this oral & easier to administer treatment has a similar efficacy & safety profile, as the current standard of care - ie an injectable version (ie iSRL) of the long-acting octreotide/lanreotide drug.
Here 91% of #Mcapssa patients maintained their response vs 100% for iSRLs, with both versions having comparable safety characteristics. Albeit 47% of the iSRL participants reported injection site reactions - of which 81% said these interfered with their daily lives.
The MPOWERED study was designed to support (or otherwise) Mycapssa's ongoing EU approval - with submission of the drug's full application to the EMA expected in Q2'22.
Meaning that if authorised, European Acromegaly patients - by switching to Mycapssa from iSRLs - might also soon have the option of taking a capsule version of octreotide, as opposed to receiving regular injections.
Not only hopefully improving patient outcomes, but also importantly reducing the burden on over-stretched healthcare systems.
Wrt materiality, Amryt Pharma plc estimates that approx 8,000 adult acromegaly patients are presently treated with iSRLs in the US.