SEC recommends approval for MSN Laboratories’ sleep disorder drug
Posted on November 15, 2024 Updated on November 10, 2024
The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.
The drug is a generic form of US-based Harmony Biosciences’ brand Wakix, a first-in-class medication for treatment of excessive daytime sleepiness (EDS) or cataplexy in patients with narcolepsy.
MSN Laboratories presented a bioequivalence study report, justification of phase III local clinical trial waiver, and literature data on prevalence of disease, with the SEC for neurology and psychiatry related matters.
“After detailed deliberation, the committee recommended for grant of market authorisation with the condition to conduct phase-IV clinical trial,” said the recommendations of an SEC meeting held on October 29, 2024.
The company is required to submit phase-IV study protocol to the Central Drugs Standard Control Organisation (CDSCO) within the period of three months of grant of market authorization for further evaluation by the committee.
The committee noted that there is limited information of disease prevalence in the Indian population.
Further, the drug has a novel mechanism of action as compared to the drugs approved for narcolepsy and there is unmet need, it observed.
It also recommended that in the prescribing information of the product, the company should include CYP2D6 Genotype determination before initiation of treatment.
Harmony Biosciences holds a US patent for the small molecule oral drug Wakix, which is due for expiry on February 25, 2029. According to a study conducted last year on behalf of Department of Pharmaceuticals, under the ministry of chemicals and fertilisers, Zydus Cadila, Abbott, Sun Pharma, Zuventus, Macleods, Mankind, Cipla and Torrent are considered as potential Indian generic manufacturers for the drug.
Harmony Biosciences has also filed a suit against MSN Laboratories and its US arm MSN Pharmaceuticals Inc., in the end of 2023 for allegedly infringing its patent by filling an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA). The company alleged that the generic versions would infringe its three patents filed with the US authorities.
Wakix, also used for treatment of EDS in paediatric patients of six years and above with narcolepsy, was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for treatment of cataplexy in 2018, claims the US company.
The company, at the end of October, said during the third quarter financial year results announcement that Wakix surpassed $2 billion in cumulative net revenue in less than five years on the market.
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