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Boehringer's Ofev scores first-of-its-kind FDA approval in rare lung disease

Published on 10/09/19 at 11:03am

Boehringer Ingelheim’s Ofev (nintedanib) capsules have now secured marketing authorisation in the US, it has emerged, for the treatment of interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD), a rare lung condition.

The decision, made under the FDA’s Priority Review pathway, was supported by data which demonstrated that the drug reduced lung function decline compared to placebo, and makes Ofev the first and only FDA-approved therapy to slow the rate of decline in this condition,

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

Affecting around 100,000 patients in the US, schloderma is characterised by the thickening and scarification of the body’s tissues, including those in the lungs and other organs. As the disease progresses, lung function worsens, even to a point where it can become potentially life-threatening through a loss of pulmonary function.

“This is the first FDA-approved therapy to slow the rate of decline in pulmonary function for systemic sclerosis-associated interstitial lung disease and provides hope to patients and their loved ones facing this devastating disease,” commented Dr Thomas Seck, Senior Vice President, Medicine & Regulatory Affairs, at Boehringer Ingelheim. “This approval is supported by positive evidence from the Phase 3 study that showed Ofev significantly slowed the progression of lung function decline in this patient population and exemplifies Boehringer Ingelheim’s dedication to the rare disease community.”

Matt Fellows

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