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2w ago

FDA Approves Palsonify, First Once-Daily Oral Treatment for Acromegaly

Crinetics targets an early-October U.S. launch supported by its CrinetiCARE access program.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
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Overview

  • The approval covers first-line use in adults whose acromegaly persisted after surgery or who are not candidates for surgery.
  • Paltusotine is a selective somatostatin receptor type 2 nonpeptide agonist formulated as a once-daily oral tablet.
  • In PATHFNDR-1, 83% of patients on paltusotine maintained IGF-I at or below the upper limit of normal at 36 weeks versus 4% with placebo (P < .0001).
  • In PATHFNDR-2, 56% of treatment-naive adults reached IGF-I at or below the upper limit of normal at 24 weeks compared with 5% on placebo (P < .0001).
  • Across both trials, participants receiving paltusotine reported reductions in acromegaly signs and symptoms, and the company is launching CrinetiCARE for education, coverage navigation, financial assistance, and nurse support.