Merck hopes to resubmit the NDA for Cladribine January 31 (NASDAQ:MKGAY)

Cladribine Tablets is a drug for young adults, especially females, who are suffering from multiple sclerosis (MS), which is a neurological disorder that affects the nerve cells in the spinal cord and the brain. The drug has been developed by Merck KGaA (NASDAQ:MKGAY.PK). Merck KGaA is a German-based pharmaceutical company. Its US subsidiary is known as EMD Serono Inc. On September 30, 2009, the company announced that it has submitted the new drug application (NDA) to get the approval of Food & Drug Administration (FDA) to market Cladribine Tablets. According to the Prescription Drug User Fee Act, the United States of America’s toughest regulator FDA had to review the submitted NDA within 60 days from September 30. This date is known as the Prescription Drug User Fee Act date (also called Action date or just PDUFA date). This is the date on which the Food & Drug Administration must respond to Merck KGaA’s application for marketing approval of Cladribine Tablets. Although the FDA did respond to the application within due time, the response was not favorable for Merck KGaA. On November 30, 2009, Merck KGaA announced that the FDA had reviewed the NDA of Cladribine Tablets and found out the NDA does not contain sufficient information for allowing a thorough review, i.e. the NDA has NOT been accepted for filing. The company expects to hold a meeting with the FDA to know what other information they should include in their new drug application. The company hopes to resubmit its NDA on January 31, 2010.

Elmar Schnee, who is the head of the Merck Serono Division and also a member of the Executive Board, said:

“The Company will work closely with the FDA to fully understand FDA’s concerns and define a path forward for a successful resubmission of this application at the earliest point in time. We remain focused on delivering on our promise to transform the way people living with multiple sclerosis approach their therapy options.”

If the resubmitted NDA gets approved by the FDA eventually, Cladribine Tablets will be the first drug that can be taken orally to decrease the frequency of relapses in people suffering from multiple sclerosis. The most common type of multiple sclerosis is the relapsing form, which makes the lives of many young adult sufferers difficult through symptoms such as lack of coordination, weakness, difficulty in seeing, and tingling or lack of sensation in the hands or legs. Cladribine Tablets aims to alleviate such symptoms.

“If approved, short-course therapy with Cladribine Tablets could transform the way people approach their treatment options”, said Fereydoun Firouz, who is the Chief Executive Officer and also the President EMD Serono. “And meet an unmet need as an oral, disease modifying drug available for MS. We look forward to working with the FDA during the course of the regulatory process.”

The previous submitted new drug application of Cladribine Tablets contained the results of the CLARITY study. This study took place over a period of two years. It was a form of “randomized”, “double-blind”, “placebo-controlled” Phase III trial. According to the company, the previous application also proved that all objectives – primary or secondary – of the CLARITY trial have been fulfilled.

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