Aubagio wins approval for treatment of patients with multiple sclerosis

Sanofi China announced on July 25 that the China National Drug Administration has approved Aubagio for the treatment of patients with relapsing multiple sclerosis in China, making it the first oral medication approved in China for multiple sclerosis.

Jean-Christophe Pointeau, Country Chair of Sanofi China, said: "Sanofi is proud to introduce one more innovative cutting-edge drug to Chinese patients. The approval of Aubagio marks the beginning of the era of oral DMT treatment for multiple sclerosis in China. It will help significantly improve patient compliance, effectively reduce the frequency of relapses, and delay the progression of disability. We sincerely appreciate the Chinese government’s determination and efforts in accelerating patients' access to innovation drugs. We also want to pay tribute to all the involved stakeholders, in particular the medical experts, for their strong support and advocacy. The majority of patients with multiple sclerosis are young and middle-aged individuals. The disease casts heavy pressure on patients and their families. We will work with our partners to enable Aubagio to benefit patients as early as possible, because we know the earlier patients have access to Aubagio,the earlier they will receive treatment and relief for their disease."

Multiple sclerosis is a lifelong, chronic and progressive disease. Due to autoimmune disorders, the myelin sheath is attacked, causing damage to the spinal cord, brain and optic nerves. The damage disrupts the nervous system, forcing patients to lose self-care ability, go blind or even lose their lives. The disease usually begins between the ages of 20 and 40, and is 1.5 times to twice as common in women as in men.

About 2.3 million people are affected globally, with a morbidity rate of 0.03 percent. The prevalence rates in Europe and the United States are higher than in Asian populations. Despite the lack of large-scale epidemiological data, it is estimated that China has a multiple sclerosis patient population of over 30,000. In May 2018, multiple sclerosis was included on China’s "First List of Rare Diseases."

Professor Cui Liying from the Department of Neurology at Peking Union Medical College Hospital pointed out that as a rare disease, multiple sclerosis has low public awareness. Because patients'initial symptoms vary, clinical diagnosis for the first episode tends to be delayed. The disease may relapse under multiple periods and scenarios, resulting in the prevalence of disability.

China is challenged by limited therapies and a huge medical burden over the treatment of multiple sclerosis.

Aubagio has proved its efficacy in patients with relapsing multiple sclerosis under four randomized, controlled, double-blind clinical trials. Among them, data from two Phase III clinical studies, the TEMSO and the TOWER, showed that patients with relapsing multiple sclerosis receiving Aubagio had significantly reduced the annualized relapse rate and delayed disability progression compared to a placebo, with sustained efficacy for up to 10 years in the expanded study., In the TOWER study, in the sub-group of Chinese patients receiving Aubagio, the relative risk of annualized relapse was lowered by 71.2 percent, while the relative risk of annualized relapse for the entire Aubagio group globally was reduced by 36.3 percent.

"Most patients with multiple sclerosis have different symptoms," said Professor Hu Xueqiang from the Department of Neurology at the Third Affiliated Hospital of Sun Yat-sen University. "For them, new treatment options will mean more possibilities for improving the quality of their lives. We clinicians are also in urgent need of more therapies to treat patients with disease progression. As a new option, Aubagio is able to significantly reduce the relapse rate while showing excellent tolerance profiles. The therapy is also easy to use, which can effectively boost patient compliance and greatly improve prognosis."

Aubagio has been approved in more than 70 countries and regions worldwide, and has benefited more than 85,000 patients in the process of treatment with multiple sclerosis.