Dr. Reddy's Siponimod Tablets Recommended for Marketing Approval in India for SPMS Treatment
Key Insights
Dr. Reddy's Laboratories' Siponimod tablets (0.25 mg, 1 mg, and 2 mg) receive SEC recommendation for market authorization for secondary progressive multiple sclerosis (search) (SPMS (search)) treatment.
The approval is contingent on Dr. Reddy's conducting Phase IV clinical trials to further evaluate the drug's efficacy and safety in the Indian population.
The SEC advises including CYP2C9 Genotype determination in the prescribing information, as individuals with this genotype should not use the drug.
The Subject Expert Committee (SEC) has recommended granting market authorization for Dr. Reddy's Laboratories' Siponimod tablets for treating secondary progressive multiple sclerosis (search) (SPMS (search)) in India. The recommendation covers Siponimod tablets in strengths of 0.25 mg, 1 mg, and 2 mg.
The SEC's decision is based on a review of the latest data presented by Dr. Reddy's, including data on the prevalence of SPMS (search) in India. The committee has suggested that Siponimod could be considered under the orphan drug category, given the rarity of SPMS. The committee also emphasized the importance of CYP2C9 Genotype determination before initiating treatment with Siponimod, as individuals with this genotype should not use the drug. This precaution is already in place in other regions where Siponimod is approved.
Phase IV Trial Requirement
As a condition of the market authorization, Dr. Reddy's is required to conduct Phase IV clinical trials to further assess the drug's performance in the Indian population. The company must submit the Phase IV study protocol to the Central Drugs Standard Control Organisation (CDSCO) within three months of receiving market authorization.
Siponimod: An Oral Treatment for SPMS
Siponimod, marketed by Novartis as Mayzent, is the first oral treatment specifically indicated for active SPMS (search) in adults. SPMS is an advanced stage of multiple sclerosis (search) (MS), an autoimmune disease affecting the brain and spinal cord. Novartis reported that up to 80% of patients with relapsing-remitting MS (RRMS) will eventually develop SPMS, highlighting the significant unmet need addressed by Siponimod.
Background on Siponimod Approval in India
In October 2020, the SEC recommended granting Novartis permission to import and market Siponimod in India for SPMS (search), waiving the requirement for local clinical trials. The current recommendation for Dr. Reddy's formulation follows an earlier SEC review in June 2024, where the committee requested additional data on the prevalence of SPMS and genetic polymorphism in India before granting approval. Dr. Reddy's subsequently submitted bioequivalence study results and data on disease prevalence, leading to the current positive recommendation.