Roche (RHHBY) and Boehringer Ingelheim each secured U.S. approvals for their competing lung disease drugs Esbriet and Ofev, according to an announcement from the U.S. Food and Drug Administration.
The FDA approval of Esbriet means U.S. patients suffering from idiopathic pulmonary fibrosis (IPF) -- a progressive and fatal disease characterized by the build-up of scar tissue in the lungs -- finally gain access to the same drug already used to treat European IPF patients since early 2011. Esbriet was developed by InterMune, which was acquired by Roche in August for $8.3 billion.
The concurrent FDA approval of Boehringer's Ofev is the first for the drug anywhere in the world.
A Roche spokesperson said Esbriet will cost $94,000 per year and will be made available to U.S. IPF patients within 10 days. Boehringer has not yet issued an announcement about Ofev launch plans or pricing.
There are about 128,000 IPF patients in the U.S., with 48,000 new cases diagnosed each year, according to the Coalition for Pulmonary Fibrosis. Both Esbriet and Ofev are approved to treat mild to moderate IPF, which affects between 30,000 and 50,000 people in the U.S.
“It's a wonderful scenario for us to be able to choose between two drugs. They are very similar,” said Dr. David Lederer of New York Presbyterian/Columbia University Interstitial Lung Disease Program in an interview earlier this week.
Perhaps because Esbriet has been approved in Europe for three years, familiarity with the drug among U.S. patients is relatively high, Lederer added. "IPF patients are very aware of pirfenidone [Esbriet's generic name] and they have certainly been calling us and other centers."
Neither drug has been compared directly against each other in clinical studies, although results from their respective phase III studies were published in the same issue of the New England Journal of Medicine in May.
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