Amryt’s Mycapssa Receives the EMA’s COMP Positive Opinion Recommending Orphan Disease Designation for the Treatment of Acromegaly
Shots:
- The EMA’s COMP has adopted a positive opinion recommending ODD of Mycapssa for acromegaly
- The COMP positive opinion was based on the efficacy & safety data from 3 P-III studies in acromegaly patients incl. the P-III (MPOWERED) trial. The recommendation to maintain ODD for Mycapssa underlines the great benefit over currently available injectable forms of somatostatin analogs for acromegaly patients in the EU
- Mycapssa was approved in the US for long-term maintenance treatment in acromegaly patients who have responded to & tolerated treatment with injectable octreotide or lanreotide. The company plans to develop oral therapies that are currently only available as injectable therapies through the TPE technology platform
Ref: Globenewswire | Image: Amryt
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