The battle to win US approval for the first multiple sclerosis (MS) pill has been stepped up after German firm Merck resubmitted a request for regulatory approval for its cladribine drug.
Merck officials met US regulators in January about getting the go-ahead for cladribine, which is also under review in Europe, but had been given no firm timescale since resubmitting. The firm’s shares were unchanged at the opening of the German stock market on Tuesday.
The news comes after Swiss pharmaceutical company Novartis released data on April 13 which showed its rival oral MS treatment, Gilenia, had cut relapse rates in the disease. Gilenia has already been given priority review status in the US and experts are to vote this week on whether to recommend approval for the drug.
Novartis had claimed an advantage over Merck last November when the US Food and Drug Administration delayed the German company’s application to introduce cladribine to the market. Merck said, however, that its treatment remains on schedule to be released on the European market.
Copyright Press Association 2010