Crinetics Pharmaceuticals Announces the European Commission Approval of PALSONIFY® (Paltusotine) for the Treatment of Acromegaly in Adults
View original at finance.yahoo.comCrinetics Pharmaceuticals Announces the European Commission Approval of PALSONIFY® (Paltusotine) for the Treatment of Acromegaly in Adults Crinetics Pharmaceuticals, Inc…
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The most frequently reported adverse reactions with paltusotine were diarrhea, abdominal pain, nausea, and abdominal discomfort.
60% confidenceTreatment with PALSONIFY was generally well-tolerated, with no serious adverse events reported in the randomized controlled portion of the trial.
60% confidenceThe EC approval of PALSONIFY is valid in all 27 member states of the EU and three European Economic Area countries.
60% confidencePALSONIFY is accelerating to become the new standard in acromegaly care in the U.S. and soon abroad.
60% confidenceAcross both PATHFNDR-1 and PATHFNDR-2 Phase 3 trials, PALSONIFY consistently demonstrated rapid onset, reliable biochemical control, and sustained efficacy.
60% confidenceTrial participants reported significant reductions in acromegaly signs and symptoms including headaches, joint pain, sweating, fatigue, weakness, swelling, and/or numbness/tingling as measured by the Acromegaly Symptom Diary (ASD).
60% confidenceThe European Commission's decision to approve Palsonify reflects the strength of the clinical data and marks a pivotal step toward bringing this important therapy to even more people living with acromegaly.
60% confidencePALSONIFY is the first once-daily, oral therapy approved to treat acromegaly in the European Union.
60% confidenceCrinetics is pursuing its vision to become the global leader in endocrinology.
60% confidence