US FDA sees safety issue with Merck hepatitis drug

A proposed Merck & Co medicine eliminated the liver-destroying hepatitis C virus although anemia and other safety concerns remained for the potential blockbuster pill, US drug reviewers said. Food and Drug Administration staff, in documents released on Monday, also noted suicidal and homicidal thoughts reported by a small number of patients.

Industry analysts said the safety findings were not strong enough to derail the drug given its high cure rate for a disease that infects tens of millions of people around the world. Analysts said they expected an advisory panel to recommend approval on Wednesday. The pill, boceprevir, and a proposed rival from Vertex Pharmaceuticals Inc are considered possible blockbuster products because of their potential to cure far more people 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. Merck shares rose 0.9 per cent to close at $34.33 on the New York Stock Exchange. Vertex shares fell 2.7 per cent to close at $48.04 on the Nasdaq.