U.S. regulators requested more information on Merck KGaA’s multiple sclerosis pill cladribine, shutting the German drugmaker out of the market for new treatments for the crippling disease.
The Food and Drug Administration asked for more analysis or additional studies to get a better understanding of the drug’s risks, Darmstadt-based Merck said in a statement today. 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, it said.
Merck had planned to compete with Switzerland’s Novartis AG, whose drug Gilenya became the first pill to combat multiple sclerosis when it won U.S. approval in September. Now the German drugmaker 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.
Merck withdrew its European application to sell cladribine last month after regulators in September said the drug’s benefits don’t outweigh its risks. Cladribine, originally a cancer drug, is sold in Russia and Australia under the brand name Movectro.
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