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SEC recommends marketing approval for Dr Reddy's SPMS drug Siponimod tablets
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Gireesh Babu, New Delhi
November 08 , 2024
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The Subject Expert Committee (SEC), which advises the national drug regulator on approval of new drugs and clinical trials, has recommended grant of market authorisation for Dr Reddy's Laboratories' Siponimod tablets in three strengths on condition that the company should conduct phase IV clinical trials.
The recommendation is for approval of Siponimod tablets 0.25 mg, 1 mg and 2 mg, for treatment of secondary progressive multiple sclerosis (SPMS), an advanced stage of autoimmune disease of multiple sclerosis.
A recent meeting of the SEC for neurology and psychiatry considered the company's request in the light of the latest data and results presented by the company. It concluded that the data on prevalence of SPMS in the Indian Scenario, presented by the company, shows that the drug can be considered under orphan drug category, to treat rare diseases in the country.
"After detailed deliberation, the committee recommended that in the prescribing information of product, firm should include CYP2C9 Genotype determination before initiation of treatment," it said.
Those who have CYP2C9 Genotype should not use the drug and determining the presence of genotype in advance has been recommended for the drug elsewhere also.
The committee recommended the grant of market authorisation with the condition to conduct phase IV clinical trials.
"The firm is required to submit phase IV study protocol to CDSCO within the period of three months of grant of market authorisation for further evaluation by the committee," it added.
Siponimod, branded by Swiss-drug major Novartis as Mayzent, is reportedly the first oral treatment indicated for active SPMS in adults. Novartis, while announcing its FDA approval for Mayzent in 2019, said that upto 80 per cent of patients with relapsing remitting MS will develop SPMS and the drug addresses a critical unmet need for RRMS patients in transition and those with active SPMS who have transitioned.
In India, the SEC recommended grant of permission for Novartis to import and market the drug only for the indication of SPMS with local clinical trial waiver in October, 2020.
SEC's latest recommendation for Dr Reddy's formulation follows an earlier recommendation in June 24, 2024, when it considered the company's request for approval with local phase III clinical trial waiver and bioequivalence waiver for lower strength.
The committee during then considered to take opinion from the ICMR regarding the indication for the proposed new drug and observed that there is no complete set of data on the prevalence of the disease and the genetic polymorphism of SPMS in public domain. Hence, it sought the company to submit the relevant data on prevalence of the disease and genetic polymorphism of SPMS.
It was in light of this advice, the company presented the BE study result and data on prevalence of the disease in the Indian scenario.
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