Nintedanib receives FDA breakthrough designation for chronic fibrosing ILD
Boehringer Ingelheim announced that the FDA has granted nintedanib breakthrough therapy designation for chronic fibrosing interstitial lung disease with a progressive phenotype, according to a press release.
The designation for nintedanib (Ofev), which is currently under FDA review, was supported by results from the INBUILD trial that were recently presented at the European Respiratory Society International Congress and published in The New England Journal of Medicine.
Nintedanib previously received breakthrough designation and was later approved in 2014 for treatment of patients with idiopathic pulmonary fibrosis. In September, the FDA also approved the drug as a treatment for patients with systemic sclerosis-associated ILD.
“We believe Ofev may help address an unmet medical need by providing a therapy for patients across a spectrum of ILDs with a progressive phenotype,” Thomas Seck, MD, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim, said in the release. “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.”