Drugs Xagena
The FDA ( Food and Drug Administration ) has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio ( Teriflunomide ) in the product’s U.S. label.
In the TOWER study, patients with relapsing multiple sclerosis receiving Teriflunomide 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo.
In addition, a significant reduction in annualized relapse rate was observed in patients treated with Teriflunomide 7 mg compared to placebo.
The TOPIC study was designed to assess whether initiation of Teriflunomide in patients who experienced their first neurological symptoms suggestive of multiple sclerosis could prevent or delay a second clinical attack ( relapse ).
In this study, the proportion of patients free of relapse was statistically significantly greater for Teriflunomide 14 mg and 7 mg, compared to placebo.
Results of the TOPIC study were published in The Lancet Neurology.
Aubagio was approved by the FDA in September 2012 based on data from the phase III TEMSO study, in which patients with relapsing multiple sclerosis who received Teriflunomide 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo.
Patients who received Teriflunomide 7 mg had a statistically significant reduction in annualized relapse rate compared to placebo.
Pooled safety analyses from more than 2,000 patients who received Teriflunomide in all three phase III studies were added to the label.
In the multiple sclerosis clinical studies with Teriflunomide, the incidence of serious adverse events were similar among Teriflunomide and placebo-treated patients. Serious events may include decreased white blood cell count, peripheral neuropathy, skin reactions and increased blood pressure.
The most common adverse events associated with Teriflunomide in patients with multiple sclerosis included headache, diarrhea, nausea, alopecia and increase in ALT.
Teriflunomide is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Teriflunomide is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system ( CNS ). ( Xagena )
Source: Genzyme, 2014
XagenaMedicine_2014
