2020-03-11| Trials & Approvals

Boehringer Ingelheim’s Ofev Becomes First FDA Approved Treatment for Progressive Interstitial Lung Diseases

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

Chronic Fibrosis interstitial lung diseases (ILD) are a group of diseases characterized by irreversible lung scarring or damage that makes it difficult for the lungs to extract enough oxygen. A chronic fibrosis ILD can be treated until a certain point, but once it becomes progressive, meaning the tissue damage worsens without further lung injury, the existing treatment options become ineffective. In the most severe cases, ILD can worsen the quality of life and decrease life expectancy by three to five years.

However, after a long wait, there is good news for patients affected by this progressive disease. Boehringer Ingelheim’s flagship product, Ofev (nintedanib) was originally FDA approved for idiopathic pulmonary fibrosis, one of the most common types of ILD and systemic sclerosis (an ultra-rare autoimmune type of ILD). Last September, it received additional approval to slow the rate of decline in pulmonary function in adults with ILD associated with SSc-ILD. Today, the U.S. FDA announced Ofev’s approval for patients with chronic fibrosis interstitial lung diseases with a progressive phenotype. This is the first time a drug is FDA approved for this indication. The nod followed a phase 3 clinical trial in which the drug outcompeted placebo in terms of slowing the decline of forced vital capacity-a test for the lung function-in 663 adult patients for 52 weeks. This popular ILD drug has consistently been able to impress the investors through its upward growth trend of 29% in 2018 and 22% in the first half of 2019.

Banu Karimi-Shah, acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research shared his views on the approval and said, “The FDA continues to encourage the development of therapies for patients with limited or no treatment options. Today’s approval helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases have not had an approved medication until now.”

This multi-targeted tyrosine kinase inhibitor will cover about 18% to 32% of patients with about 200 separate diseases that include unclassifiable ILDs, autoimmune ILDs, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, Sjogren’s syndrome, coal workers pneumoconiosis and idiopathic forms of interstitial pneumonia.

Roche’s Esbriet (pirfenidone) which rivals Ofev in treating Idiopathic Pulmonary Fibrosis, is also currently evaluated under clinical trials for unclassifiable progressive fibrosing interstitial lung disease. As Boehringer celebrates Ofev’s approval, the company is simultaneously making plans to extend its portfolio in the fibrosis category. Earlier this year, it signed a multi-billion-euro deal with Enleofen for IL-11 inhibitors for the fibrotic disease of the lungs, liver and other organs. The company also signed deals with Bridge Biotherapeutics for an Ofev follow-up and with South Korea’s Yuhan Corporation on a first-in-class dual agonist for the treatment of non-alcoholic steatohepatitis and related liver diseases.

Related Article: Boehringer Ingelheim’s New Drug – Nintedanib – Lowers Pulmonary Fibrosis by 57%



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