Eli Lilly Gets CDSCO Panel Nod To Import, Market Lasmiditan for acute treatment of migraine
New Delhi: Citing that the global clinical trial data demonstrate the efficacy and safety of Lasmiditan for the acute treatment of migraine with and without aura, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to drug major Eli Lilly to import and market Lasmiditan 50 mg and 100 mg tablets.
This approval is subject to the condition that the firm conduct a Phase IV clinical trial of the product in the country, for which a protocol should be submitted to CDSCO within two months of the drug's approval.
This came after the drug major Eli Lilly presented its proposal to import and market Lasmiditan 50 mg and 100 mg tablets, along with a global Phase III clinical trial report, before the committee.
Lasmiditan is an oral 5HT1F agonist used for the acute treatment of migraine headache with or without aura. Lasmiditan was first approved for use in the United States in October 2019. It was also approved by the European Commission on August 17, 2022.
Lasmiditan belongs to a class of medications called selective serotonin receptor agonists. Lasmiditan may work by stopping pain signals from being sent to the brain and stopping inflammation of the nerves that cause symptoms of migraine. Lasmiditan can alleviate migraine through 5-HT1F agonist activity that leads to inhibition of neuropeptide and neurotransmitter release and inhibition of PNS trigeminovascular and CNS pain signalling pathways.
At the recent SEC meeting for neurology and psychiatry held on February 15, 2023, the expert panel reviewed the proposal presented by the drug major Eli Lilly for the approval of the import and marketing of the Lasmiditan tablets, along with global Phase III clinical trial reports.
The committee noted that Lasmiditan tablets, 50 mg and 100 mg, are approved in countries like the U.S.A., Japan, and the European Union, etc. Furthermore, it added that the global clinical trial data demonstrated the efficacy and safety of the drug for the acute treatment of migraine with and without aura.
After detailed deliberation, the committee recommended the grant of permission to import and market Lasmiditan 50 mg and 100 mg tablets, subject to the conditions that the firm should conduct a Phase IV clinical trial in the country for which a protocol should be submitted to CDSCO within two months of the drug's approval for further review by the committee.
Also Read:CDSCO panel seeks data for Eli Lilly's anticancer drug selpercatinib
