Vertex seeks fast approval for drug
Hepatitis therapy, 15 years in the making, has a rival
Fifteen years after it began developing a hepatitis C treatment around which it is building is business, Vertex Pharmaceuticals Inc. yesterday applied for approval to sell the drug — filing about a million pages.
In its application to the Food and Drug Administration, the Cambridge company seeks priority review for the drug, called telaprevir. It wants the FDA to make a decision in six months rather than the usual 10 months, on the grounds that telaprevir represents a major advance in treatment of the virus.
If the request is granted and the application is approved, Vertex could begin selling its first commercial drug by spring.
While the market for the new class of hepatitis C treatments is projected to swell to billions of dollars annually over the coming decade, Vertex will have competition.
Merck & Co. is developing a similar treatment and is expected to apply for FDA approval by the end of the year. But by completing the filing of its long-awaited and voluminous application Monday night, Vertex got a jump on New Jersey-based Merck.
“It’s the new standard of care,’’ Vertex’s chief executive, Matthew Emmens, said yesterday.
“There’s about 4 million people in the United States infected by hepatitis C. This treatment represents a better chance of getting a cure and a faster treatment for patients.’’
FDA officials are expected to notify Vertex within 45 days whether they will agree to a priority review.
The treatment Vertex has been testing in late-stage clinical trials combines telaprevir — a protease inhibitor that acts directly against the virus — with two drugs currently on the market, pegylated interferon and ribavirin. Together, they cut the existing treatment regimen for the disease in half, to 24 weeks.
Merck declined to comment.
Merck’s competing drug, boceprevir, another protease inhibitor, also has reduced treatment times and demonstrated comparable cure rates in clinical trials.
Both companies released promising late-stage trial results this month at the annual meeting of the American Association for the Study of Liver Disease in Boston.
While drug development typically takes 10 years or more, the telaprivir program was especially long and difficult because it was a first-in-class drug targeting a virus for which current treatments often don’t work.
Vertex had to host separate clinical trials for hepatitis C patients who had never been treated and patients whose past treatments had not proved effective. The trials enrolled about 2,500 patients.
An estimated 3 million people don’t even know they have hepatitis C. The disease has become an epidemic among baby boomers infected decades ago through injecting drugs or blood transfusions. It is believed to kill about 10,000 people a year, many of whom develop scarring of the liver or cancer.
Vertex, founded in 1989, has been building a specialized sales and marketing team for telaprevir, increasing its workforce by 300 to 1,625 this year as it prepares to introduce the treatment.
Robert Weisman can be reached at email@example.com.