FDA hands Merck KGaA a new delay on cladribine

The FDA has tacked a three-month extension onto its review of Merck KGaA'S cladribine, a closely-watched MS therapy that was recently dealt a major setback in Europe after the EMA recommended against approval.

Once in a hot race with Novartis' Gilenya, another oral MS therapy that won U.S. approval in September, cladribine has steadily slipped back over the course of 2010. Earlier this year, the FDA handed Merck's application back, saying it needed more work before it could be accepted for review. Now analysts are wrangling over whether this new delay could mark a potential comeback, signifying a possible approval.

European regulators were spooked by evidence of cancer in drug trials. The FDA will now have until February 28 to determine if it's equally leery of a therapy once hailed as a major advance for MS patients. The drug has been approved in Russia and Australia.

- get the Merck KGaA release
- read the story from Reuters
- here's the report from the Wall Street Journal