submit pool data along with Indian patient data: CDSCO panel Tells MSN Laboratories Over Vigabatrin Tablets
New Delhi: In response to the proposal presented by the drug major MSN Laboratories to manufacture and market the antiepileptic drug Vigabatrin, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the pool data along with Indian patient data and meta-analysis of concurrent therapy of the proposed drug Vigabatrin.
This came after MSN Laboratories presented its proposal for manufacturing and marketing Vigabatrin tablets 250 & 500 mg along with justifications for waiver of local clinical trial and Bioequivalence study before the committee.
Vigabatrin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Vigabatrin is a medication used in the management and treatment of infantile spasms and refractory complex partial seizures. It is in the anti-epileptic class of medications.
Vigabatrin was rationally designed to have a specific effect on brain chemistry by inhibiting the GABA-degrading enzyme, GABA transaminase, resulting in a widespread increase in GABA concentrations in the brain. The increase in GABA functions as a brake on the excitatory processes that can initiate seizure activity.
Vigabatrin is indicated as adjunctive therapy in the treatment of refractory complex partial seizures in patients 2 years of age and older who have had inadequate responses to multiple previous treatments (i.e. not to be used for first-line therapy).
At the recent SEC meeting for Neurology and Psychiatry held on 17th August 2023, the expert panel reviewed the proposal for the manufacture and marketing of Vigabatrin tablets 250 & 500 mg.
The firm informed that Vigabatrin 250mg strength is proposed for dose titration or pediatric use, which is not yet approved anywhere in the world.
After detailed deliberation, the committee recommended that the firm submit pool data along with Indian patient data and meta-analysis of concurrent therapy of the proposed drug to the CDSCO for further review by the committee.
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