Two Oral MS Drugs Recommended by European Regulators


March 22, 2013

European Union (EU) drug regulators yesterday announced that they are recommending approval of 2 new oral drugs — dimethyl fumarate (Tecfidera, Biogen Idec) and teriflunomide (Aubagio, Genzyme/Sanofi) — to treat adult patients with relapsing-remitting multiple sclerosis (MS).

The US Food and Drug Administration (FDA) just approved teriflunomide in September 2012. The agency now is considering whether to greenlight dimethyl fumarate, also called BG-12, as well. If that happens, it would be the third oral agent for this indication here, joining teriflunomide and fingolimod (Gilenya, Novartis).

Two clinical trials, CONFIRM (Comparator and an Oral Fumarate in Relapsing–Remitting Multiple Sclerosis) and DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in Relapsing–Remitting MS), funded by Biogen and published last September in the New England Journal of Medicine, found that dimethyl fumarate reduced relapse rates, disease activity on imaging, and, in 1 trial, the progression of disability.

The European Medicines Agency (EMA) said in a press release that its Committee for Medicinal Products for Human Use (CHMP) deemed the "benefit-risk balance" to be favorable for the MS drug.

Flushing and gastrointestinal problems, such as diarrhea, nausea, and abdominal pain, are the drug's most common adverse events.

Teriflunomide Nod Follows Latest TOWER Findings

The CHMP recommendation of teriflunomide follows positive findings from the clinical trial TOWER (Teriflunomide Oral in People with Relapsing-remitting Multiple Sclerosis). The final results of TOWER, released last fall, confirmed that, like dimethyl fumarate, the drug reduces the rate of relapse and disability progression in patients with MS. TOWER was 1 of 3 clinical trials that figured into the FDA's approval of teriflunomide last year.

The most common adverse events with teriflunomide are upper respiratory and urinary tract infections, diarrhea, nausea, paraesthesia, alopecia, and an increase in alanine aminotransferase.

The CHMP recommendations on teriflunomide and dimethyl fumarate go to the European Commission, the executive branch of the EU, for approval.

More information on yesterday's EMA announcement on the 2 drugs is available on the agency's Web site.