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The benefit with Aubagio® is its ability to reduce the relapse rate in patients with relapsing remitting multiple sclerosis. The most common side effects are upper respiratory tract infections, urinary tract infections, diarrhoea, nausea, paraesthesia (pins and needles), alopecia (loss of hair) and increase in the liver enzyme alanine aminotransferase. A pharmacovigilance plan for Aubagio® will be implemented as part of the marketing authorisation.

* On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Aubagio® 14 mg film-coated tablet intended for the treatment of multiple sclerosis. The Committee also concluded that the active substance contained in Aubagio®, teriflunomide, could not be considered to be a new active substance.The benefit with Aubagio® is its ability to reduce the relapse rate in patients with relapsinrosis Oral) trial. In the Phase III TEMSO trial, Aubagio® 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with relapsing forms of multiple sclerosis. Aubagio®7 mg significantly reduced the annualized relapse rate (p=0.0002) in the trial. In MS 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 MS patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia. The labeling for Aubagio® was also informed by the estimated 2.1 million years of patient exposure globally since the launch of leflunomide, which is indicated in the U.S. for the treatment of rheumatoid arthritis. Teriflunomide is the principal active metabolite of leflunomide. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide. 

* On September 12, 2012, Genzyme announced that the FDA has approved Aubagio® as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). The FDA approval was based on efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. In the Phase III TEMSO trial, Aubagio® 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with relapsing forms of multiple sclerosis. Aubagio® 7 mg significantly reduced the annualized relapse rate (p=0.0002) in the trial. The ongoing AUBAGIO clinical development program, involving more than 5,000 patients in 36 countries, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years. The Aubagio® label includes a boxed warning citing the risk of hepatotoxicity and, teratogenicity (based on animal data). In MS clinical studies with Aubagio®, the incidence of serious adverse events were similar among Aubagio®O and placebo-treated patients. The most common adverse events associated with Aubagio® in MS patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia.

The labeling for Aubagio® was also informed by the estimated 2.1 million years of patient exposure globally since the launch of leflunomide, which is indicated in the U.S. for the treatment of rheumatoid arthritis. Teriflunomide is the principal active metabolite of leflunomide. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide.

*On February 23, 2012, Genzyme has announced that the EMA has accepted the filing of the marketing authorization application (MAA) for once-daily oral teriflunomide for the treatment of relapsing forms of multiple sclerosis (MS). Acceptance of the MAA starts the EMA’s review process. The purpose of the MAA is to secure approval to market and allow prescription of teriflunomide in the European Union based on data from two completed pivotal Phase III trials, TEMSO and TENERE. TENERE results have been reported in December 2011. These trials represent two of five efficacy studies of teriflunomide in MS that are completed or underway, making the clinical program one of the largest and broadest of any MS therapy in development. 

* On December 20,2011, Genzyme has announced that it expects to file an application for marketing authorization with the EMA in the first quarter of 2012.  The FDA application for teriflunomide was accepted for review by the FDA in October 2011. g remitting MS. The most common side effects are upper respiratory tract infections, urinary tract infections, diarrhoea, nausea, paraesthesia (pins and needles), alopecia (loss of hair) and increase in the liver enzyme alanine aminotransferase. A pharmacovigilance plan for Aubagio® will be implemented as part of the marketing authorisation.