First treatment approved for progressive interstitial lung diseases – Boehringer Ingelheim

Pharma News: Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approval of Ofev (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype – encompassing more than 200 disorders and classified as rare diseases.

“The FDA continues to encourage the development of therapies for patients with limited or no treatment options,” said Banu Karimi-Shah, M.D., acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “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.”

Ofev, a multi-targeted tyrosine kinase inhibitor that inhibits key pathways involved in lung fibrosis in ILDs, is currently approved for idiopathic pulmonary fibrosis (IPF) and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD (SSc-ILD), two types of ILDs. This new approval now makes Ofev available for patients with chronic fibrosing ILDs in which lung fibrosis continues to worsen.

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The FDA approval is based on the INBUILD trial, the first Phase III clinical trial in the field of ILDs to group patients based on the clinical behaviour of their disease rather than the primary clinical diagnosis.

“Chronic fibrosing ILDs with a progressive phenotype lead to respiratory symptoms and worsening lung function,” said Kevin Flaherty, M.D., professor of medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan in Ann Arbor, Michigan, and lead investigator of the INBUILD trial. “This approval provides a therapeutic option for many patients who did not have an approved treatment until today.”

Interstitial lung diseases encompass more than 200 disorders, which are classified as rare diseases, that can lead to pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function. Chronic fibrosing ILDs in which lung fibrosis continues to worsen are estimated to occur in 18 to 32 percent of patients with ILDs.

“As a leader in the field of ILD research, we are fully committed to better understanding how to treat these devastating diseases,” said Thomas Seck, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Today’s approval marks a major advancement in ILD research and is an important milestone just six months after the approval of Ofev to slow the rate of decline in pulmonary function in patients with SSc-ILD.”

“Patients with a progressive form of chronic fibrosing ILDs may have symptoms that are similar to other respiratory illnesses and that may delay getting an accurate diagnosis for patients,” said Greg Cosgrove, M.D., chief medical officer, Pulmonary Fibrosis Foundation. “The new indication for nintedanib provides a therapeutic option for physicians and their patients as there is now a treatment option that can help slow the decline in lung function.”

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