The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Ofev (nintedanib) to preserve lung function in people with systemic sclerosis (SSc)-associated interstitial lung disease (SSc-ILD) in the European Union.
Boehringer Ingelheim, the company marketing Ofev, submitted the request for this indication in March 2019. The European Commission will review the opinion by CHMP, an arm of the European Medicines Agency (EMA), before making its decision.
“SSc-ILD is a life-changing disease. Once fibrosis [scarring] of the lungs occurs it cannot be reversed, and this can have a devastating impact on a patient’s life and daily activities,” Peter Fang, senior vice president and head of therapeutic area inflammation at Boehringer, said in a press release.
“Striving to improve the lives of people living with pulmonary fibrosis, we are pleased with the Committee’s positive opinion, which represents an important step forward in helping to slow down the progression of this rare and life-changing disease,” he added.
CHMP’s positive recommendation, like the approvals in the U.S., Canada and other countries, is based on the positive results of the Phase 3 SENSCIS trial (NCT02597933). The study evaluated the safety and effectiveness of Ofev in 576 patients with SSc (or scleroderma)-ILD. Participants were recruited at more than 100 clinical sites across 32 countries.
Patients were randomly assigned to either 150 mg of Ofev or a placebo twice daily for a year (52 weeks).
The trial’s primary goal was to assess the annual rate of decline in forced vital capacity (FVC) — a measure of lung function defined as the amount of air a person can forcibly exhale after a deep breath.
Results showed that after one year of treatment, patients using Ofev had a significantly slower decline in lung function (44% lesser decline in FVC) compared with those on a placebo.
Treatment was overall well-tolerated, with more than 80% of the patients finishing the 52-week trial. Diarrhea, the most common side effect, was more prevalent in the Ofev group. Other common side effects included nausea, vomiting, abdominal pain, weight loss, and fatigue. This safety profile was similar to the one observed in people with idiopathic pulmonary fibrosis treated with Ofev.
The positive results obtained in the SENSCIS trial are similar to those seen in a more recent Phase 3 study (NCT02999178), named INBUILD, which evaluated the therapeutic benefits of Ofev in people with ILDs with progressive fibrosis.
The findings showed that treatment with Ofev significantly slowed lung function decline — 57% less than with a placebo — over one year of treatment. An additional analysis showed that Ofev induced similar benefits in people with progressive fibrosis ILD specifically associated with autoimmune diseases, including scleroderma.
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