FDA Extends Review of Cladribine for MS

Merck Serono's not out the race to market an oral pill for multiple sclerosis in the United States. Not yet. Although it appears to be hobbling, rather than running, toward some kind of finish line.

Friday the company announced that the FDA is extending its original 6-month priority review of cladribine by another 3 months. Why the FDA needs the extra review time is unclear, but a company spokesperson told Bloomberg that the agency is not requesting additional clinical trials.

The prospect for cladribine's FDA approval remains murky, given a thumbs-down opinion from the European Medicines Agency in September. However, the drug is currently approved for the treatment of MS in Russia and Australia.

In September, the FDA approved Novartis's oral MS pill, Gilenya, with a number of safety caveats—including the institution of a REMS (Risk Evaluation and Mitigation Strategy) program and a pregnancy registry. The drug is priced at $4000 per month, wholesale, with a company-sponsored program to (slightly) ease the financial burden for patients. The web site destinationrx.com offers 30, 0.5-mg capsules for $4268.16.

At the blog/web site inThought (from Wolters Kluwer Pharma Solutions; sign-up required), the immediate uptake of Gilenya is anticipated to be tempered by neurologists' concerns about safety and cost. But the company still expects worldwide sales of $1.5 billion by 2017.

Merck Serono's hobbled racehorse, still standing.