Boehringer Ingelheim’s Drug Ofev Approved by FDA

Sept. 6, 2019, 7:41 PM UTC

The U.S. Food and Drug Administration approved Boehringer Ingelheim‘s drug Ofev (nintedanib), which has become the first treatment to be approved by the agency for a rare lung condition -- interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD.

  • Ofev capsules to slow rate of decline in pulmonary function in people with SSc-ILD
  • Ofev was originally approved in 2014 for adult patients with idiopathic pulmonary fibrosis (IPF), which is another interstitial lung condition
  • Ofev received priority review designation and orphan drug designation
  • NOTE: July 25, FDA Panel Recommends Approval of Boehringer Ingelheim’s Ofev

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