NDA Submission of Paltusotine for Acromegaly скачать в хорошем качестве

NDA Submission of Paltusotine for Acromegaly

Alan Krasner, MD, Chief Medical Officer of Crinetics Pharmaceuticals, discusses the new drug application (NDA) submission of paltusotine for treating acromegaly. Acromegaly is a rare hormonal disorder resulting from the overproduction of growth hormone in the pituitary gland. It is most often diagnosed in middle-aged adults, although symptoms can appear at any age. Signs and symptoms include abnormal growth and swelling of the hands and feet; bone changes that alter various facial features; arthritis; carpal tunnel syndrome; enlargement of body organs; and various other symptoms. The condition is usually caused by adenomas on the pituitary. Rarely, it is caused by tumors of the pancreas, lungs, and other parts of the brain. Paltusotine is an investigational, once-daily, oral, selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide agonist. In phase 3 studies of paltusotine for the treatment of acromegaly, the medication illustrated the ability to maintain IGF-1 levels and symptom control in patients who switched from monthly injectable medications (PATHFNDR-1). It also rapidly decreased IGF-1 levels and symptom burden in patients who were medically untreated prior to paltusotine (PATHFNDR-2). A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) for paltusotine in the treatment of acromegaly. The NDA is supported by data from the PATHFNDR trials, where all primary and secondary endpoints were met and safety and tolerability was favorable. Recently, the FDA has announced its acceptance of the NDA for paltusotine with a PDUFA data of September 25, 2025.