The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended the approval of Ofev (nintedanib) for the treatment of progressive fibrosing interstitial lung diseases (ILDs).
This positive opinion follows Ofev’s approval for that same indication in the U.S. and Canada. If accepted by the European Commission, which makes the final decision based on CHMP’s recommendation, Ofev — marketed by Boehringer Ingelheim — will become the first medication approved in the European Union (EU) for ILD patients whose chronic fibrosis continues to worsen over time.
“Pulmonary fibrosis is a major challenge for people suffering with ILDs and can lead to irreversible harm to the lungs, resulting in worsening respiratory symptoms and reduced quality of life,” Peter Fang, senior vice president and head of therapeutic area inflammation at Boehringer Ingelheim, said in a press release.
“We are very pleased with the Committee’s opinion, which can bring a new therapy to people where there are no currently approved treatment options available,” Fang added.
Ofev eases lung tissue scarring (fibrosis) by targeting signaling molecules involved in the deposition of collagen and in the growth and maturation of fibroblasts — cells involved in the formation of scar tissue.
CHMP’s recommendation was based on findings from the INBUILD Phase 3 trial (NCT02999178), which demonstrated that Ofev brings significant benefits to patients with a range of progressive fibrosing ILDs.
ILDs are a group of more than 200 conditions that may lead to scarring in the lungs, and up to one-third of patients with ILDs other than IPF are estimated to develop a progressive fibrosing disease course. This is associated with a faster deterioration in lung function, worse quality of life, and early mortality.
INBUILD enrolled 663 adults who were randomly assigned to Ofev or a placebo capsule, taken twice a day for one year (52 weeks). Its primary goal was to determine if Ofev was better than a placebo at lowering the annual rate of lung function decline — assessed through changes in forced vital capacity (FVC, the amount of air a person can exhale after a deep breath) at week 52.
Secondary measures included changes in health-related quality of life, the length of time before an acute exacerbation, and time to death.
Results showed that patients in the Ofev group experienced an 80.8 mL yearly reduction in their FVC, which was significantly less than the 187.8 mL lost in the placebo group over the year. This meant Ofev slowed the rate of lung function decline by 57% compared to the placebo.
Treatment also showed a trend toward a better health-related quality of life, a delay in the time to acute exacerbations or death, and fewer deaths due to any cause, but these measures did not reach statistical significance. However, cough and shortness of breath were significantly eased with Ofev treatment.
Importantly, the benefits across primary and secondary endpoints were consistent across all patients, regardless of their underlying ILD diagnosis. Safety and tolerability was also consistent with what was seen in prior IPF and scleroderma-associated ILD clinical trials.
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