Oral cladribine to be the first oral disease-modifying multiple sclerosis therapy despite receiving RTF letter

Jan 6 2010

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a recent "refuse to file" (RTF) letter issued by the Food and Drug Administration (FDA) regarding Merck Serono's oral cladribine has heightened the competition between oral cladribine and its primary competitor, Novartis/Mitsubishi Tanabe's FTY-720 (fingolimod), to be the first oral disease-modifying multiple sclerosis therapy to reach the market in the United States.

The Pharmacor finding from the topic entitled Multiple Sclerosis reveals that, although oral cladribine's first-to-market advantage over FTY-720 will be reduced as a result of a likely delay to market caused by the FDA's action, oral cladribine is still expected to launch in the U.S. in 2010 while FTY-720 remains on track to launch in early 2011. Merck Serono, which has not released details about the contents of the letter that its U.S. affiliate EMD Serono received from the FDA in late 2009, has indicated that it is in discussions with the FDA regarding the resubmission of the new drug application for oral cladribine.

"Typically, the FDA will issue an RTF letter if some aspect of a new drug application is incomplete but this action is not a reflection of the FDA's opinion regarding a drug's efficacy or safety profiles," said Decision Resources Analyst Bethany Kiernan, Ph.D. "At this time, we assume the RTF letter will not significantly delay the 2010 launch of oral cladribine in the United States."

At this time, the FDA's letter regarding oral cladribine has not impacted the report's market forecasts for oral cladribine or FTY-720. The report finds that, in 2018, oral cladribine and FTY-720 will together capture more than $2 billion in sales in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.