FDA has granted to Boehringer Ingelheim a breakthrough therapy designation for Ofev, for Chronic Fibrosing ILDs with a Progressive Phenotype, after the study results from the Phase III testing met its primary endpoint and was recently published in the New England Journal of Medicine.
Ofev is currently under FDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, Boehringer said, noting that the regulatory applications have been submitted to other regulatory bodies, including the European Medicines Agency.
Thomas Seck, senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, said: “We are encouraged by this Breakthrough Therapy Designation and look forward to working closely with the agency to offer this therapy to patients for which there are no FDA-approved treatment options.”
The Breakthrough Therapy Designation process was established by the FDA to expedite the development and review of drugs for serious or life-threatening conditions where preliminary clinical evidence indicate that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. In July 2014, the FDA granted nintedanib Breakthrough Therapy Designation for the treatment of people with idiopathic pulmonary fibrosis (IPF) and approved the drug for that use in October 2014.