Crinetics Pharmaceuticals, Inc. announced on March 27, 2025, that the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for paltusotine. This oral, once-daily somatostatin receptor type 2 nonpeptide agonist is for the proposed treatment of acromegaly.
The MAA will now undergo review by the Committee for Medicinal Products for Human Use (CHMP). Additionally, the EMA granted paltusotine Orphan Drug Designation (ODD) for acromegaly on February 27, 2025.
The MAA submission is supported by data from 18 clinical trials, including two Phase 3 trials that met all primary and secondary endpoints. Orphan designation provides benefits such as reduced regulatory fees and potential for 10 years of market exclusivity, underscoring the global potential and unmet need for paltusotine.
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