Indian SEC Recommends Approval for MSN Laboratories' Pitolisant for Narcolepsy
• The Subject Expert Committee (SEC) in India has recommended granting market authorization to MSN Laboratories for Pitolisant tablets, a generic version of Wakix.
• The recommendation is contingent upon MSN Laboratories conducting a Phase IV clinical trial and submitting the study protocol to the CDSCO within three months.
• The SEC noted the limited data on narcolepsy prevalence in India and recognized Pitolisant's novel mechanism of action and the unmet need in treating the condition.
• The committee also recommended including CYP2D6 genotype determination in the prescribing information before initiating treatment with Pitolisant.
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