Sanofi and its subsidiary Genzyme have announced that the European Commission has granted marketing authorization for Aubagio ( Teriflunomide ) 14 mg, a once-daily, oral therapy indicated for the treatment of adult patients with relapsing remitting multiple sclerosis ( RRMS ).

The EU approval of Aubagio was based on data from the Phase III TEMSO ( TEriflunomide Multiple Sclerosis Oral ) and TOWER ( Teriflunomide Oral in people With relapsing remitting multiplE sclerosis ) trials.
In these trials, Aubagio significantly reduced the annualized relapse rate and the time to disability progression at two years versus placebo.

Multiple sclerosis is estimated to affect more than 2.1 million people globally. There are approximately 630,000 people affected by multiple sclerosis in Europe.

Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system ( CNS ).

Aubagio is a once-daily, oral therapy indicated in the United States for the treatment of adult patients with relapsing forms of multiple sclerosis. The recommended dose of Aubagio is 7 mg or 14 mg orally once daily.

The Aubagio label includes the risk of hepatotoxicity and, teratogenicity ( based on animal data ).

In clinical studies with Aubagio, the incidence of serious adverse events were similar among Aubagio and placebo-treated patients. The most common adverse events associated with Aubagio in multiple sclerosis patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia.

Teriflunomide is the principal active metabolite of Leflunomide ( Arava ), which is indicated in the U.S. and Europe for the treatment of rheumatoid arthritis. Severe liver injury including fatal liver failure has been reported in patients treated with Leflunomide.
Leflunomide has an estimated 2.1 million patient years of exposure in rheumatoid arthritis globally since its launch.

Aubagio is contraindicated in patients with severe hepatic impairment, pregnant women and women of childbearing potential who are not using reliable contraception, breast feeding women, patients with immunodeficiency states, patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia, patients with severe active infection until resolution, patients with severe renal impairment undergoing dialysis and patients with hypoproteinaemia. ( Xagena )

Source: Genzyme, 2013

XagenaMedicine2013