UPDATE – FDA approves two treatments from Roche, Boehringer for fatal lung disorder
Originally posted by Natalie Grover with Reuters, edited by Simon Jennings
* First-ever U.S. approvals for idiopathic pulmonary fibrosis
* Roche’s Esbriet to be priced at about $94,000 per year
* Esbriet expected to generate sales of about $1.04 billion in 2019 (Adds pricing details for Roche drug)
The U.S. health regulator approved two treatments for use in idiopathic pulmonary fibrosis (IPF), marking its first-ever approvals for the fatal lung disease that has no clear etiology and no cure.
The first, Esbriet, was developed by InterMune Inc, which Switzerland-based Roche Holding AG agreed to buy for $8.3 billion in August, banking largely on the treatment’s potential.
Privately held German drugmaker Boehringer Ingelheim’s rival drug nintedanib, which will be sold under the brand name Ofev, also won U.S. Food and Drug Administration approval on Wednesday. (1.usa.gov/1qwyxk5)
The agency’s decision marks a crucial milestone in the management of the disease, which affects about 100,000 people in the United States.
IPF is characterized by scarring that thickens the lining of the lungs, causing an irreversible loss of the tissue’s ability to transport oxygen.
Roche’s drug, known generically as pirfenidone, is already sold in Europe and Canada to slow the progression of the often misdiagnosed, ultimately fatal disorder. (1.usa.gov/1qwx6Cj)
Esbriet, which joins Pulmozyme and Xolair in Roche’s respiratory portfolio, is expected to launch within two weeks at an annual cost of about $94,000, Roche said.
Dr. Paul Noble, who says he was involved in the development of both drugs, believes that Roche’s pirfenidone will be prescribed more frequently than Boehringer’s nintedanib, at least until U.S. doctors become comfortable with the latter.
There is a lot more experience with pirfenidone as it has been studied for the better part of a decade, he said.
“The key differentiating factor of InterMune’s drug seems to be in the reduction of all-cause mortality,” Helvea analyst Odile Rundquist said.
The FDA rejected Esbriet in 2010, going against the recommendations of an independent review committee and asking for a fresh trial to prove the drug’s effectiveness.
Data from this pivotal late-stage study showed that Esbriet was more effective than a placebo.
Esbriet, which rakes in sales of about $150 million a year in Canada and Europe, is expected to generate about $1.04 billion in 2019, according to Thomson Reuters Pharma.
Pirfenidone, like nintedanib, acts as “promiscuous inhibitor” of the action of multiple growth factors believed to be behind the scarring in IPF, said Noble, who is director of the Women’s Guild Lung Institute at Cedars-Sinai.
Other drug developers, including Gilead Sciences Inc , Bristol-Myers Squibb and Biogen Idec, also have IPF drugs in mid-stage development.
The future lies in a combination treatment that can actually reduce scar tissue, Noble said.
Roche shares closed down about 2 percent at 258.90 Swiss francs ($275.27) on the SIX Swiss Exchange.
($1 = 0.9405 Swiss francs)