Breakthrough status from FDA for Ofev in ILDs

The US Food and Drug Administration has granted Breakthrough Therapy designation to Ofev (nintedanib), which is currently under FDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

Regulatory applications have been submitted to other regulatory bodies, including the European Medicines Agency, says the drug’s developer, family-owned German pharm major Boehringer Ingelheim, which took in $1.2 billion sales last year and $747.4 million in the first half of this year in Ofev’s current approved indications.

Clinical backing