Teva's Multiple Sclerosis Therapy Glatiramer Acetate (Branded as Glatopa®/Copaxone®) Approved in China, Offering New Treatment Option for Relapsing MS Patients

——Provide New Treatment Options for Chinese Patients

ShanghaiJune 28, 2023PR Newswire -- Teva China (Teva) announced that the National Medical Products Administration (NMPA) of China has recently officially approved "Glatiramer Acetate Injection." The registered trademark of this drug is Copaxone.^®、Copaxone^®, hereinafter referred to as Gupaisong^®. This medication is indicated for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis. The approved specifications (20mg/ml and 40mg/ml) have both received approval from the U.S. Food and Drug Administration (FDA). Notably, the 40mg/ml specification reduces the frequency of weekly dosing, enhancing patient compliance and convenience.

Multiple sclerosis is an immune-mediated inflammatory demyelinating disease of the central nervous system, with common clinical manifestations including recurrent episodes of vision loss, double vision, limb sensory disturbances, limb motor dysfunction, ataxia, and bladder or rectal dysfunction. According to statistics, there are approximately 2.8 million people with multiple sclerosis globally (as of 2020), with an incidence rate of 0.235 per 100,000 per year in China.Person^[1], is the most common cause of permanent disability in young adults other than traumaEtiology^[2]。

Classic drugs, balancing efficacy with long-term safety

Gupaisong^®It is the acetate of a synthetic polypeptide composed of four natural amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. As a first-line disease-modifying treatment for adult patients with relapsing multiple sclerosis, Copaxone.^®Approved in more than 50 countries worldwide, with over 27 years of clinical application, showing definite efficacy and demonstrating good long-term safety and tolerability.

Nearly 30 years of clinical research data have confirmed^[3-15], Gu Pa Song^®Can significantly reduce the recurrence rate and disease activity, improve patients' disability progression and brain atrophy, lower the risk of clinically isolated syndrome progressing to multiple sclerosis, and also alleviate symptoms such as fatigue, cognitive dysfunction, and spasticity. Additionally, Copaxone...^®Long-term safety is good, with no significant time-dependent adverse reactions, and monitoring is not necessary unless under special circumstances.

Focus on Patients of Childbearing Age, Meet Urgent Clinical Needs

According to statistics, multiple sclerosis predominantly affects young and middle-aged adults, with a higher proportion of female patients in their childbearing years. Research shows that some female patients delay disease-modifying treatment significantly due to family planning, increasing the risk of disability progression. For female patients who are planning pregnancy, experience unintended pregnancy, or are in the lactation period, current treatments often involve discontinuation of medications, and some disease-modifying drugs even require rapid washout. This indicates that the urgent clinical needs of patients in their childbearing years remain unmet.

Teva^®It is currently the only first-line disease-modifying treatment (DMT) drug recommended by both Chinese and international guidelines for use in pregnant and breastfeeding female patients. Its application in pregnant and breastfeeding women has not been associated with an increased risk of adverse pregnancy outcomes or fetus/newborn-related risks, providing robust safety assurance for women of childbearing age.

Mr. Huang Diren, General Manager of Teva Greater China, stated:"Very pleased to witness GuPaiSong^®The accelerated approval in China reflects the country's determination and action to expedite the review and approval of innovative drugs, addressing the urgent clinical needs of patients. Upholding a patient-centric philosophy, Teva will continue to focus on the most pressing clinical needs of Chinese patients, committing to introduce more globally innovative products into China for the benefit of patients and contributing to 'Healthy China 2030'."Add 'ladder' and 'tile'."

References

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