Chiasma announces submission of Marketing Authorization Application for oral octreotide capsules (Mycapssa) to European Medicines Agency as a maintenance therapy for adults with acromegaly
Submission is supported by data from phase 3 MPOWERED trial (n=146), which met its primary endpoint of non-inferiority of Mycapssa compared to long-acting somatostatin analog injectables. The capsules are licensed in US;octreotide is currently only available as an injection in EU
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Biospace Inc.