Boehringer Ingelheim recently announced that OFEV (nintedanib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a treatment for idiopathic pulmonary fibrosis (IPF) within the National Health Service (NHS) in England and in Wales.
Nintedanib, an oral small molecule tyrosine kinase inhibitor, is recommended for use in IPF patients with a predicted forced vital capacity (FVC) of 50 percent to 80 percent, and who do not experience disease progression marked by a FVC decline of 10 percent or more in a 12-month period. The NICE committee’s decision was based on clinical findings that the drug reduced the decline in pulmonary function, as assessed by FVC, compared to placebo.
“This NICE recommendation for OFEV® is very welcome news for patients in England and Wales who have this devastating disease, as it gives doctors a much needed new option in the management of IPF. At Boehringer Ingelheim, we have over 90 years of experience in the field of respiratory medicine and are delighted to be leading the way in bringing this novel medicine to people with IPF,” Professor Klaus Dugi, medical director and managing director, Boehringer Ingelheim, U.K. and Ireland, said in a press release.
Specifically, the committee looked at the results of three multicenter, randomized, placebo-controlled, and double-blind clinical trials: the Phase 3 INPULSIS 1 (comprising 513 patients) and INPULSIS 2 (comprising 548 patients), and the Phase 2b dose-ranging TOMORROW trial (comprising 428 patients).
In all three trials, treatment with nintedanib was compared to placebo in IPF patients for a study period of 52 weeks. The trials’ primary endpoint was the rate of decline in forced vital capacity. Results showed that OFEV both reduced the annual rate of decline in FVC and lessened the risk of exacerbations in comparison with placebo.
“Having been involved in the NICE appraisal process, Action for Pulmonary Fibrosis is very pleased that nintedanib has been approved for the treatment of patients with IPF. With no cure and very limited treatment options, nintedanib offers an alternative therapy which will be much welcomed by patients,” said Mike Bray, chair of Action for Pulmonary Fibrosis.