STAT+: Crinetics wins FDA approval for acromegaly drug, faces competition with Novartis and Ipsen
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SAN DIEGO \u2014 Crinetics Pharmaceuticals won Food and Drug Administration approval on Thursday for a drug for a rare and debilitating hormonal disorder \u2014 the company\u2019s first approved product. But the treatment faces competition from pharma giants with blockbuster medicines already on the market.<\/p>\n
The therapy, Palsonify, was approved after a pair of late-stage trials found<\/a> the once-a-day pill significantly lowered levels of growth hormone, which is overproduced in patients with acromegaly. These studies also found that the drug was generally safe and well tolerated. The FDA greenlit Palsonify as a first-line therapy for adults with acromegaly who are either ineligible for surgery or did not have an adequate response to surgery. The drug will have an annual cost of $290,000, the company shared on a call with investors after the approval announcement.<\/p>\n \u201cToday marks a new era for those living with acromegaly and also for Crinetics as a company,\u201d said CEO Scott Struthers in a statement. \u201cWe are very pleased to be fulfilling our commitment to transforming patient lives.\u201d<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n