Boehringer Ingelheim cast a wide net with its clinical program for pulmonary fibrosis med Ofev, hoping to carve out a sales niche in a huge range of ultrarare lung diseases. Already sporting an FDA nod in one subclass, Ofev can now target an even larger patient pool with its newest approval.
The FDA on Monday approved Ofev to treat patients with range of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, Boehringer said in a release.
Ofev's newest approval covers between 18% and 32% of total patients with an ILD, a category that includes around 200 diseases that can lead to irreversible scarring of lung tissue, Boehringer said.
Ofev already sports FDA approvals to treat pulmonary fibrosis and systemic sclerosis-associated ILD (SSc-ILD), another subclass of ILDs that is believed to affect about 50,000 Americans each year.
The FDA based its review on data from Boehringer's phase 3 Inbuild study, which showed Ofev significantly slowed the rate of lung function decline in patients with a range of progressive, non-IPF ILDs by 57% over placebo after 52 weeks.
Inbuild on the whole studied Ofev in a wide range of ILDs, including those with a progressive phenotype and SSc-ILD, the drugmaker said, an indication where Ofev notched an FDA nod in September. That approval––the first of its kind––followed a phase 3 clinical trial, dubbed Senscis, in which Ofev beat out placebo in terms of slowing the decline of forced vital capacity—a measure of lung function—in 576 patients treated for a minimum of 52 weeks and maximum of 100 weeks.
Ofev received its initial approval in idiopathic pulmonary fibrosis back in 2014.