Shots:
- The EC has approved Palsonify (paltusotine) for treating adults with acromegaly who are ineligible for or inadequately respond to surgery across all 30 EEA states
- EC approval was supported by P-III PATHFNDR-1 & PATHFNDR-2 trials evaluating Palsonify in previously treated & medically untreated adults with acromegaly, demonstrating rapid onset, reliable biochemical control & sustained efficacy; it also received ODD in EU
- Crinetics plans initial Palsonify commercialization in Germany & Austria, partnered with Sanwa Kagaku Kenkyusho for Japan, where paltusotine received orphan drug designation & an NDA was filed; an MAA was also submitted to Brazil’s ANVISA
Ref: Crinetics Pharmaceuticals | Image: Crinetics Pharmaceuticals | Press Release
Related News:- Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly
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