Boehringer's Ofev recommended for NHS use by NICE

Following a full technology appraisal of German family-owned pharma major Boehringer Ingelheim’s Ofev (nintedanib) is now recommended for use within the National Health Service (NHS) in England and Wales by medicine watchdog, the National Institute for Health and Care excellence (NICE) for patients with idiopathic pulmonary fibrosis (IPF)

In coming to its decision, the NICE Appraisal Committee considered the clinical evidence for nintedanib from three multicenter, double-blind, placebo-controlled, randomized trials comprising two Phase III trials (INPULSIS 1 [n=513] and INPULSIS 2 [n=548]) and a Phase IIb dose-ranging trial (TOMORROW [n=428]). All three trials compared nintedanib with placebo for 52 weeks in adults of 40 years or older with IPF. The primary outcome was the rate of decline (ml per year) in forced vital capacity (FVC).The trials demonstrated Ofev significantly slowed the annual rate of decline in FVC in patients with IPF. Ofev was the first targeted treatment for IPF to consistently meet its primary endpoint in two international Phase III trials with identical design.

Additionally, in a pooled analysis of the three Phase II/III trials nintedanib reduced the risk of having one or more exacerbation compared to placebo.