Reuters Health Information (2011-04-26): US FDA panel backs efficacy of Vertex hepatitis drug
US FDA panel backs efficacy of Vertex hepatitis drug
Last Updated: 2011-04-26 17:06:16 -0400 (Reuters Health)
WASHINGTON (Reuters) - Vertex Pharmaceuticals Inc's drug telaprevir is effective for treating hepatitis C, U.S. Food and Drug Administration reviewers said in documents released on Tuesday.
"Overall, the FDA review team's independent analyses confirmed the applicant's primary efficacy findings" on telaprevir, FDA staff said in a summary prepared for an advisory panel that will evaluate the drug on Thursday.
The FDA reviewers said they would ask the panel to discuss rashes and anemia seen in clinical trials of telaprevir. Those issues were known and analysts do not expect them to derail the drug's approval.
ISI Group analyst Mark Schoenebaum said the reviewer comments were a "near best-case" for the drug. Some investors had worried the FDA might focus on rare problems seen in studies but those were only briefly mentioned, he said.
The Vertex medicine and a possible rival from Merck & Co are expected to transform treatment of hepatitis C.
Both pills are considered possible blockbuster products because the medicines may cure far more patients and in as little as half the time of standard drugs. Current therapies require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate.
An FDA panel will review the Merck drug, boceprevir, on Wednesday. In documents released on Monday, agency reviewers said Merck's drug appeared effective but highlighted anemia and other safety issues for panel discussion.
The FDA usually approves medicines that win advisory panel backing.