Boehringer Ingelheim bags Ofev FDA approval for SSc-ILD

Ofev FDA approval for SSc-ILD : The US Food and Drug Administration (FDA) has extended approval for Boehringer Ingelheim Pharmaceuticals’ Ofev (nintedanib) capsules for the treatment of a particular condition associated with systemic sclerosis or scleroderma.

The latest FDA approval for Ofev is for its use in slowing the rate of decline in pulmonary function in adults with interstitial lung disease associated with scleroderma (SSc-ILD). According to the FDA, Ofev is the first treatment for the rare lung condition to get its approval.

Scleroderma results in thickening and scarring of tissue across the body, including the lungs and other organs. Interstitial lung disease is a condition that affects the interstitium, which is part of the lung’s structure, and is among the most common disease manifestations of the rare lung condition.

SSc-ILD is a progressive lung disease in which functions of the lungs deteriorates over time. The condition can be debilitating and also life-threatening.

The FDA originally approved Ofev in 2014 for the treatment of idiopathic pulmonary fibrosis (IPF) in adults. Idiopathic pulmonary fibrosis is also an interstitial lung condition.

Ofev is a kinase inhibitor that has been designed to inhibit growth factor receptors like the vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor receptor (FGFR).

Boehringer Ingelheim secures Ofev FDA approval for SSc-ILD. Photo courtesy of Boehringer Ingelheim Pharmaceuticals, Inc.

Nikolay Nikolov – associate director for Rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, commenting on the Ofev FDA approval for SSc-ILD, said: “Patients suffering from scleroderma need effective therapies, and the FDA supports the efforts of drug companies that are designing and conducting the clinical trials necessary to bring treatment options to scleroderma patients.

“Nintedanib is now a treatment option to slow the rate of decline in pulmonary function in patients who have interstitial lung disease from scleroderma.”

Ofev’s ability to treat SSc-ILD was evaluated in a randomized, double-blind, placebo-controlled trial featuring 576 patients, aged 20-79 years. Patients were on the treatment for 52 weeks, with some of them treated up to 100 weeks.

The primary test for efficacy evaluated the forced vital capacity (FVC) – a measure of lung function, defined as the volume of air that can be exhaled forcibly from the lungs after taking the deepest breath possible. Patients subjected to Ofev had less decline in their lung function compared to those treated on placebo.

The overall safety profile noted in the Ofev treatment arm was in line with the known safety profile of the therapy, said the FDA.

Ofev FDA approval for SSc-ILD follows the orphan drug and the priority review designations given to it by the regulator. For more pharma regulatory news, keep following Pharma News Daily.

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