Panel to FDA: Give OK to Vertex hepatitis C drug
Silver Spring, Md. --- A medical advisory committee today unanimously recommended that the US Food and Drug Administration approve a hepatitis C drug developed by Cambridge-based Vertex Pharmaceuticals Inc. --- which could become the first new blockbuster drug developed by a Massachusetts company in seven years.
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After a day of testimony in which executives, regulators, doctors, and patients spoke of telaprevir's effectiveness but also warned of side effects such as rashes and anemia, the antiviral drugs advisory committee voted 18 to 0 to recommend approval.
"I think this is a long-awaited landmark day for patients with hepatitis C," said committee member Barbara H. McGovern, associate professor of medicine at Tufts University School of Medicine in Boston.
Citing telaprevir's markedly improved cure rate compared to those of current hepatitis C treatments, another committee member, Dr. Lawrence S. Friedman, chairman of the department of medicine at Newton-Wellesley Hospital, said, "It's a stunning achievement that we will be able to cure nearly 80 percent of [first-time] patients and nearly as many relapsers."
Trading in Vertex shares was halted by Nasdaq after back-to-back advances over the past two days. Nasdaq sometimes takes such actions to prevent speculation during hearings on drugs critical to a company's market value.
The advisory panel's vote to recommend telaprevir came a day after it voted to also recommend FDA approval of a competing drug candidate from Merck & Co., a hepatitis C drug called boceprevir.
Both Vertex's and Merck's drug candidates act by blocking the protease enzyme that enables the virus to replicate.
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