Amryt Pharma announced positive results for the MPOWERED phase 3 trial for Mycapssa® oral octreotide for acromegaly patients. The trial paves the way for the approval of Mycapssa® by the EMA, the European entity responsible for approving new medications in Europe. The findings were published in The Lancet Diabetes and Endocrinology Journal and originally released on January 4, 2022. You can read Amryt’s release here.
The FDA approved Mycapssa® delayed-release capsules in the US in June of 2020. This new oral medication is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Pituitary World News co-founder and Medical Director of the California Center for Pituitary Disorders, Dr. Lewis Blevins commented on the findings. “I’m excited to see the results of the global Phase 3 MPOWERED clinical trial that compared Mycapssa® (oral octreotide capsules) to long-acting injectable Somatostatin Receptor Ligands (iSRLs) for maintenance of biochemical response in patients with acromegaly, he said. “ The study clearly confirms the results of previous studies showing that oral octreotide capsules provide biochemical control in patients with acromegaly who respond to somatostatin receptor ligands. Oral therapy with somatostatin receptor ligands has been a desire since the inception of therapy with this class of drugs in the 1990s. The future is now!”, he added.
Dr. Mark Sumeray, Chief Medical Officer of Amryt, added: “Many patients with acromegaly experience breakthrough symptoms and significant burdens with SSA injections, including injection site pain and reactions. The publication of the MPOWERED Phase 3 results in The Lancet family of journals underscores their significance and potential clinical value of Mycapssa® for appropriate acromegaly patients.”
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