Roche And InterMune's Esbriet For IPF Approved By FDA
By Marco La Vecchia, VP Channel Sales, AVG Technologies
The U.S. Food and Drug Administration (FDA) announced its approval of Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF). Esbriet is manufactured by Roche company InterMune, which is based in Brisbane, California.
Pirfenidone is an orally active, small molecule that inhibits TGF-beta synthesis. TGF-beta is a chemical mediator that influences several cell functions such as proliferation and differentiation, and plays a crucial part in fibrosis. The drug also works against the synthesis of the cytokine, TNF-alpha, which is implicated in inflammation. The company reported that pirfenidone has shown clinical activity in a number of fibrotic conditions, including lung, liver, and kidney fibrosis. Data from three clinical trials involving 1,247 patients with IPF showed that Esbriet reduced forced vital capacity in IPF patients compared to placebo.
“Esbriet provides a new treatment option for patients with idiopathic pulmonary fibrosis, a serious, chronic lung disease. We continue to help advance medication therapies by approving products that treat conditions that impact public health,” said Curtis J. Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
The drug has received a number of designations from the FDA. These include Breakthrough Therapy status, Orphan Drug Designation, Fast Track status, and priority review. Today’s approval is ahead of Esbriet’s prescription drug user fee goal date of Nov. 23, 2014.
According to the San Francisco Business Times (SFBT), Esbriet will come with a price tag of $94,000 per year in the U.S. It will cost about $40,000 in the EU and Canada, though prices will vary.
The FDA also approved Boehringer Ingelheim’s Ofev (nintedanib) for IPF at the same time as Esbriet. Gregory Cosgrove, CMO of the Pulmonary Fibrosis Foundation, commented that the two approvals are significant in the treatment of the disease which is responsible for about 40,000 IPF-related deaths each year. As Cosgrove told the SFBT, “[The Ofev approval] changes the therapy conversation. And, importantly, it really provides hope to patients that, perhaps, we can slow the disease, treat the disease and seek a cure.”