US breakthrough designation in IPF for Boehringer’s nintedanib

The US Food and Drug Administration has granted Breakthrough Therapy designation for German family-owned pharma major Boehringer Ingelheim’s nintedanib, a treatment in idiopathic pulmonary fibrosis (IPF), a devastating and fatal lung disease.

Nintedanib is an investigational therapy currently under FDA and European Medicines Agency review for IPF. The  FDA accepted the New Drug Application for the drug earlier this month.There are currently no FDA-approved treatments for IPF.

“We’re excited nintedanib has been granted breakthrough therapy designation in the US, which we hope will make the treatment available to IPF patients as quickly as possible. Currently there are no FDA-approved treatments available for IPF. We are committed to working with all regulatory bodies to make nintedanib available to people living with this serious and life-threatening lung disease,” said Klaus Dugi, chief medical officer at Boehringer Ingelheim.