Genzyme, a Sanofi company, announced today that the Food and Drug Administration (FDA) 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 MS receiving Aubagio 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 Aubagio 7 mg compared to placebo.
The TOPIC study was designed to assess whether initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack (i.e., relapse). In this study, the proportion of patients free of relapse was statistically significantly greater for Aubagio 14 mg and 7 mg, compared to placebo. Results of the TOPIC study were published in The Lancet Neurology in September 2014.
“Aubagio is the only oral multiple sclerosis treatment that has demonstrated a positive effect on disability progression in two Phase III clinical studies and is the only oral therapy with supporting published efficacy data on the treatment of patients who have experienced a first clinical attack,” said Dr. Aaron E. Miller, Medical Director, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, The Mount Sinai Hospital. “These data, along with its consistent safety and tolerability profile, make Aubagio an important treatment option for patients with relapsing MS.”
Aubagio was approved by the FDA in September 2012 based on data from the Phase III TEMSO study, in which patients with relapsing MS who received Aubagio 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. Patients who received Aubagio 7 mg had a statistically significant reduction in annualized relapse rate compared to placebo.
“The update to the U.S. label reflects the breadth of data reinforcing the consistent efficacy of Aubagio,” said Genzyme President and CEO, David Meeker, M.D. “Aubagio is establishing itself within the MS treatment paradigm due to its efficacy, as well as its safety and tolerability as demonstrated during its two years on the market.”
Pooled safety analyses from more than 2,000 patients who received Aubagio in all three Phase III studies were added to the label. In the MS clinical studies with Aubagio, the incidence of serious adverse events were similar among Aubagio 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 Aubagio in MS patients included headache, diarrhea, nausea, alopecia and increase in ALT.
About Aubagio® (teriflunomide)
Aubagio is approved in more than 50 countries around the world, including the United States, European Union, Australia, Argentina, Brazil, Canada, Chile, Columbia, Dominican Republic, Guatemala, Honduras, Mexico, New Zealand, Panama, Peru, Russia, South Korea, Switzerland, Turkey and Ukraine, with additional marketing applications under review by regulatory authorities globally. Between clinical trials and commercial use, approximately 30,000 patients have been treated with Aubagio.
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 supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries.
U.S. Indication and Usage
Aubagio (teriflunomide) is a once-daily, oral therapy indicated 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.
Important Safety Information About Aubagio
The Aubagio label includes the risk of hepatotoxicity and, teratogenicity (based on animal data). In the United States, this information can be found in the boxed warning.
In MS clinical studies with Aubagio, the incidence of serious adverse events were similar among Aubagio 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 Aubagio in MS patients included headache, diarrhea, nausea, alopecia and increase in ALT.
Teriflunomide is the principal active metabolite of leflunomide, which is indicated in the U.S. for the treatment of rheumatoid arthritis. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide. ALT should be monitored monthly for at least 6 months in patients who start treatment with Aubagio.
Aubagio is contraindicated in patients with severe hepatic impairment, pregnant women and women of childbearing potential who are not using reliable contraception and in patients who are taking leflunomide. Aubagio is not recommended for breast-feeding women, patients with immunodeficiency states, patients with significantly impaired bone marrow function or significant anemia, leucopenia, neutropenia or thrombocytopenia, patients with severe active infection until resolution, patients with severe renal impairment undergoing dialysis and patients with hypoproteinaemia.