FRANKFURT (Dow Jones)--Pharmaceutical and chemical company Merck KGaA (MRK.XE) said Wednesday it failed to win approval for its oral multiple sclerosis drug cladribine from the U.S., pending further information, but analysts largely consider a rejection as the most likely scenario.
In a so-called complete response letter, the U.S. Food and Drug Administration drug regulator asked the German conglomerate to either provide additional analyses of study results that it had already submitted, or carry out new trials.
While the lack of approval seems a setback, analysts said it's more of a reprieve for Merck, with much of the market having expected a final FDA blow to the medicine this week.
In January an EU panel confirmed its negative opinion on the treatment, prompting analysts to remove revenues for cladribine from Merck estimates, amid low expectations that the FDA would approve it.
In a so-called complete response letter, the U.S. Food and Drug Administration drug regulator asked the German conglomerate to either provide additional analyses of study results that it had already submitted, or carry out new trials.
While the lack of approval seems a setback, analysts said it's more of a reprieve for Merck, with much of the market having expected a final FDA blow to the medicine this week.
In January an EU panel confirmed its negative opinion on the treatment, prompting analysts to remove revenues for cladribine from Merck estimates, amid low expectations that the FDA would approve it.