News Briefs: Ascendis’ Yorvipath Is Now Available

Jan 09
Jan 09, 2025

Yorvipath (palopegteriparatide) is now available in the U.S., Ascendis Pharma revealed Dec. 19. The FDA approved the prodrug of parathyroid hormone on Aug. 9, 2024, for the treatment of adults with hypoparathyroidism. The manufacturer says it is the first FDA-approved therapy for this indication. The company’s U.S. Ascendis Signature Access Program has a dedicated Yorvipath team to assist patients, caregivers and physicians.

The FDA issued a Drug Safety Communication about Intercept Pharmaceuticals, Inc.’s Ocaliva (obeticholic acid), the agency said on Dec. 12. The farnesoid X receptor agonist is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. The FDA said it had found “cases of serious liver injury” in people being treated for PBC who did not have cirrhosis. In evaluating liver safety in postmarket clinical trials involving people appropriate for treatment, the agency discovered that “the risk of both liver transplant and death were higher in patients receiving Ocaliva compared with those receiving placebo.” The agency first granted the drug accelerated approval on May 27, 2016. The FDA says that “frequent liver test monitoring is necessary to identify worsening liver function and ensure appropriate discontinuation of Ocaliva.” It noted that it had previously communicated similar risks and will continue to monitor the issue.
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Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.