FDA Approves First Oral Treatment for Group of Progressive I
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The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time.

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 randomized, 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.

The most common side effects reported in the Ofev clinical trial were diarrhea, nausea, headache and weight loss. Ofev is not recommended for patients with moderate or severe hepatic (liver) impairment. It may also cause embryo-fetal toxicity that can result in fetal harm, arterial thromboembolic events (blood clots), bleeding and gastrointestinal perforation (hole formation).

Ofev 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.The FDA granted the approval of Ofev to treat ILD with a progressive phenotype to Boehringer Ingelheim Pharmaceuticals, Inc.

Source : https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-group-progressive-interstitial-lung-diseases

Image courtesy : Boehringer Ingelheim
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Dr. S●t P●l
Dr. S●t P●l Orthopaedics
Great to know that such a medicine is available for treating some chronic lung disease
Mar 13, 2020Like1
Dr. S●t P●l
Dr. S●t P●l Orthopaedics
Great to know that such a medicine is available for treating some chronic lung disease
Mar 13, 2020Like1
Dr. S●t P●l
Dr. S●t P●l Orthopaedics
Great to know that such a medicine is available for treating some chronic lung disease
Mar 13, 2020Like