Boehringer Ingelheim's Ofev wins FDA approval for use in scleroderma patients
Five years after securing its first approval in idiopathic lung fibrosis, Boehringer Ingelheim’s drug Ofev has been cleared to slow the rate of pulmonary decline in patients with another lung scarring disease.
The approval — for patients with interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD) — marks the first FDA nod for the rare lung condition.
The agency’s endorsement was based on data from a 576-patient placebo-controlled study. The main goal of the trial was to measure lung function via forced vital capacity (FVC) — defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible — at the end of 52 weeks, although some patients were treated for up to 100 weeks.
Patients given the drug, known chemically as nintedanib, experienced a slower rate of FVC decline. Those given the placebo saw a decline of 93.3 (mL/year), versus 52.4 (mL/year) in patients on the drug (p=0.04).
On the safety side however, there were some side-effects — largely diarrhea — that led to dose reductions. Data showed 34% of Ofev-treated patients, compared to 4% of placebo-treated patients, required tweaks to their dosing.
Scleroderma is a rare condition that is characterized by the thickening and scarring of tissues — including the lungs — across the body. Interstitial lung disease (ILD) is a condition affecting connective tissue that forms the support structure of the alveoli in lungs, and is common in scleroderma. SSc-ILD, which affects roughly 50,000 Americans, causes lung function to progressively decline, and is the leading cause of death in scleroderma patients.
In the first half of this year, net sales of Ofev to treat idiopathic lung fibrosis (IPF) rose by 21.6% to 677 million euros (about $747 million) on a currency-adjusted basis.
Ofev was cleared for use in IPF in October 2014 — on the same day as rival Roche’s Esbriet, kickstarting a scramble for market share.
This July, Boehringer signed a pact with Bridge Biotherapeutics to expand its IPF arsenal. The Korean biotech has a autotaxin inhibitor, BBT-877, in early-stage development.