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Thursday, March 3, 2011

US seeks more data on MS treatment, Oral Cladribine


Bloomberg News - March 3, 2011

ZURICH — Merck KGaA failed to win US regulators’ backing for its multiple sclerosis pill cladribine, shutting the German drug maker out of the market for new treatments for the crippling disease for now.

The Food and Drug Administration asked for more analysis or additional studies to get a better understanding of the medicine’s risks, Darmstadt-based Merck said. Merck plans to seek an end-of-review meeting with the FDA to determine whether data already collected will be sufficient to address the concerns, according to the statement.

Merck had expected to compete with Switzerland’s Novartis AG, whose drug Gilenya became the first pill in the United States to combat multiple sclerosis when it won approval in September. Now the German drug maker is losing its foothold in the market as setbacks accumulate for cladribine and its older injected treatment Rebif faces competition from new therapies, said Cornelia Thomas, a London-based analyst for WestLB AG.

Without US approval for cladribine, Merck’s sales this year are likely to climb 10 to 15 percent, chief executive Karl-Ludwig Kley said last month. That compares with an estimate of 13 to 18 percent if the drug had won clearance.



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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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