Boehringer Ingelheim's Ofev cuts rate of decline by 57% in range of rare lung diseases

Boehringer Ingelheim
Boehringer Ingelheim's Ofev scored a trial win in slowing the progression of a range of rare lung diseases. (Boehringer Ingelheim)

Driven by the idiopathic pulmonary fibrosis (IPF) market, Boehringer Ingelheim’s Ofev finally hit blockbuster sales in 2018. After following that performance with an FDA nod in a rare lung disease, Ofev is targeting even more small indications to add to its portfolio.  

Ofev significantly slowed the rate of lung function decline in patients with a range of progressive, non-IPF interstitial lung diseases (ILD) by a whopping 57% over placebo after 52 weeks. Those data from Boehringer’s phase 3 Inbuild study were presented Monday at the European Respiratory Society International Congress in Madrid.

The study included patients with a range of fibrosing ILDs, a disease family with more than 200 known disorders including systemic sclerosis-associated ILD (SSc-ILD)—an indication Ofev was approved earlier this year to treat.

According to Boehringer, Ofev showed a statistically similar safety profile in treating both IPF and non-IPF lung diseases. The drugmaker said it planned to submit the newest data to international regulators “as soon as possible.”

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In a Tuesday media call, Susanne Stowasser, Boehringer’s associate head of respiratory medicine, said the data showed positive signs that Ofev could eventually be approved to treat a wide range of ILDs.

“We are now in a position that we will hopefully be soon able to offer these patients with these diseases a treatment, because they currently do not have a treatment,” she said.

That strategy was certainly the case for Ofev’s last approval in early September—in SSc-ILD—after Boehringer previously received both an FDA priority review and orphan drug designation to study the indication.

The nod followed a phase 3 clinical trial, dubbed Senscis, in which the drug beat out placebo in terms of slowing the decline of forced vital capacity—a measure of lung function—in 576 patients treated a minimum of 52 weeks and maximum of 100 weeks.  

That newest approval could help Ofev add to its sales after an impressive second quarter of growth. In that span, Ofev’s sales ballooned to €677 million, a 21.6% jump from the same period in 2018.