FDA approves Ofev for progressive interstitial lung diseases

Ofev, the first treatment for patients with chronic fibrosis interstitial lung diseases (ILD) with a progressive phenotype, has been approved in the US.

The approved from the FDA for Ofev (nintedanib) oral capsules was granted to Boehringer Ingelheim.

Chronic fibrosing ILD with a progressive phenotype encompasses a group of fibrotic lung diseases caused by different underlying diseases or conditions – including autoimmune ILD, hypersensitivity pneumonitis and idiopathic nonspecific interstitial pneumonia.

Characteristics of chronic fibrosing ILD include lung scarring and rapid disease progression, as assessed through worsening lung function tests, symptoms and/or imaging.

Progressive lung scarring leads to breathlessness and respiratory failure. Lung function declines over time among these patients and can be debilitating and life-threatening.

Ofev’s safety and effectiveness to treat chronic fibrosing ILD with a progressive phenotype in adults was evaluated in a randomised, double-blind, placebo-controlled study of 663 adults. The mean age of patients was 66 years and more patients were male (54%) than female.

The primary test for effectiveness was the forced vital capacity, which is a measure of lung function. It is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.

In the 52-week period, patients received either 150 milligrams of Ofev twice a day or a placebo. After 52 weeks, people who received Ofev had less lung function decline compared to those on the placebo.

Ofev received Priority Review designation, meaning the agency plans to take action on the application within six months because the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.

It also received Breakthrough Therapy Designation, which is designed to expedite the development and review of certain drugs intended to treat a serious condition.

The drug was previously approved to treat idiopathic pulmonary fibrosis and to slow the rate of decline in pulmonary function among patients with ILD associated with systemic sclerosis or scleroderma.

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