Added indication approved for nintedanib in Europe

The European Commission has approved an additional indication for nintedanib in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF).

The drug is marketed by family-owned German drug major Boehringer Ingelheim under the trade name Ofev, which generated sales of 1.49 billion euros ($1.7 billion) in 2019, up 31.6% year-on-year.

The approval comes after the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in May 2020. The US Food and Drug Administration, Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) recently approved nintedanib as the first treatment for the same patient population.