Ofev Approved for Treating Progressive Fibrosing ILDs in Europe

The European Commission has approved Boehringer Ingelheim‘s Ofev (nintedanib) for the treatment of progressive fibrosing interstitial lung diseases (ILDs) in adults.

The approval follows a recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP), as well as approvals for the same indication in the U.S. and Canada.

The new approval is the third for Ofev in Europe. The medication already is approved to treat idiopathic pulmonary fibrosis (IPF) and scleroderma-associated ILD.

“We are very pleased with the European Commission’s decision to approve nintedanib as the first treatment in the EU for a group of chronic fibrosing ILDs that are progressing,” Peter Fang, senior vice president and head of therapeutic area inflammation at Boehringer Ingelheim, said in a press release.

ILDs include more than 200 distinct conditions that can involve fibrosis (scarring) of the lungs, which results in decreased lung function. It has been estimated that 18–32% of people with ILDs other than IPF are at risk of developing a progressive fibrosing disease course, which is associated with a faster decrease in lung function and poorer quality of life.

Ofev works by blocking the activity of signaling pathways that drive fibrosis. The new approval was based on data from the Phase 3 clinical trial INBUILD (NCT02999178), which enrolled 663 adults with a range of progressive fibrosing ILDs. Participants were assigned randomly to Ofev or a placebo capsule, taken twice per day for one year.

The trial’s primary endpoint — that is, its main measurement to determine effectiveness — was the rate of change in forced vital capacity (FVC) after a year. FVC, which measures the amount of air a person can exhale after a deep inhalation, is a common measurement of lung function.

In the trial, Ofev-treated participants experienced an average decrease in FVC of 80.8 mL after a year. For participants given a placebo, the average decline was 187.8 mL. These results indicate that Ofev slowed the rate of lung function decline by 57% compared to the placebo.

Ofev treatment also significantly eased symptoms, including coughing and shortness of breath. Importantly, results from INBUILD showed that Ofev was similarly effective regardless of underlying ILD.

The safety profile of the medication was consistent with previous data in other populations.

“Various underlying diseases can lead to the development of pulmonary fibrosis and until now, no treatment option was available,” Fang said. “Bringing new hope to those patients constitutes a therapeutic breakthrough.”

“Making your voice heard when living with a rare life-threatening condition can be very hard and also frightening, especially if no treatment option is available,” said Liam Galvin, secretary of the European Idiopathic Pulmonary Fibrosis and Related Disorder Federation.

“The European Commission’s decision is great news for people who are at risk of developing pulmonary fibrosis due to a progressive ILD. Pulmonary fibrosis causes irreversible decline in lung function and this new indication brings much hope to those affected and their loved ones,” Galvin said.