New acromegaly drug, Palsonify from Crinetics, wins FDA approval

SAN DIEGO — Crinetics Pharmaceuticals won Food and Drug Administration approval on Thursday for a drug for a rare and debilitating hormonal disorder — the company’s first approved product. But the treatment faces competition from pharma giants with blockbuster medicines already on the market.

The therapy, Palsonify, was approved after a pair of late-stage trials found 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.

“Today marks a new era for those living with acromegaly and also for Crinetics as a company,” said CEO Scott Struthers in a statement. “We are very pleased to be fulfilling our commitment to transforming patient lives.”