The Subject Expert Committee (SEC) in India has recommended granting market authorization to MSN Laboratories, a Telangana-based pharmaceutical company, for its generic version of Pitolisant tablets. This drug is intended for the treatment of sleep disorders, specifically excessive daytime sleepiness (EDS) or cataplexy in patients with narcolepsy. The decision follows a review of MSN Laboratories' bioequivalence study report, justification for a waiver of a Phase III local clinical trial, and literature data on the prevalence of narcolepsy.
The SEC, which advises the national drug regulator on new drug approvals, made its recommendation during a meeting held on October 29, 2024. The approval is conditional, requiring MSN Laboratories to conduct a Phase IV clinical trial to further evaluate the drug's efficacy and safety 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.
Unmet Needs in Narcolepsy Treatment
The SEC acknowledged the limited information available regarding the prevalence of narcolepsy in the Indian population. Despite this, the committee recognized that Pitolisant offers a novel mechanism of action compared to existing narcolepsy treatments, addressing an unmet need in this therapeutic area. The committee has recommended that the prescribing information for Pitolisant include the determination of CYP2D6 genotype before initiating treatment.
Patent Landscape and Legal Challenges
Pitolisant is a generic version of Harmony Biosciences' Wakix, a drug protected by a US patent that is set to expire on February 25, 2029. Harmony Biosciences has taken legal action against MSN Laboratories and its US arm, MSN Pharmaceuticals Inc., alleging patent infringement related to the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA). Wakix has achieved significant commercial success, surpassing $2 billion in cumulative net revenue in less than five years. It also holds orphan drug designation for narcolepsy treatment since 2010 and breakthrough therapy designation for cataplexy treatment since 2018.
