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CDSCO Panel Mandates Phase III Trial of Baloxavir Marboxil in Indian Population

• India's drug regulatory panel has directed Roche Products India to conduct Phase III clinical trials of Baloxavir marboxil for influenza treatment, citing insufficient local patient data.

• The antiviral medication, already approved in the US, Japan, Canada, and Australia, works by inhibiting the spread of influenza virus through polymerase acidic endonuclease inhibition.

• The CDSCO committee determined that acute uncomplicated influenza does not represent an unmet medical need in India, necessitating local clinical validation.

India's drug regulatory authorities have called for additional clinical validation of the influenza antiviral medication Baloxavir marboxil, requiring Roche Products India to conduct Phase III trials specifically in the Indian population before market approval.
The Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) reached this decision after reviewing Roche's proposal to import and market Baloxavir marboxil tablets in 20 mg, 40 mg, and 80 mg strengths. The company had requested a waiver for Phase III clinical trials, presenting global clinical data and influenza prevalence statistics to support their application.

Mechanism of Action and Current Approvals

Baloxavir marboxil belongs to the polymerase acidic endonuclease inhibitor class of medications. The drug's molecular mechanism involves binding to the host RNA polymerase (Pol II segment) via the PB2 subunit, enabling the cleavage of 10–13 capped RNA fragments from pre-mRNA/mRNA. This process, known as the Cap Snatching mechanism, effectively halts viral replication within the body.
The medication has already secured regulatory approvals in several major markets, including the United States, Japan, Canada, and Australia. It is indicated for treating influenza infections in adults and children aged 5 years and older, specifically when symptoms have been present for no more than 48 hours. The drug can be administered to both otherwise healthy individuals and those at elevated risk for flu-related complications.

Regulatory Considerations and Decision

During their February 13-14, 2025 meeting, the SEC's antimicrobial and antiviral committee carefully evaluated the available data. Despite the drug's international approval status, the committee highlighted two crucial factors in their decision:
  1. Insufficient clinical data specific to Indian patients
  2. The assessment that acute uncomplicated influenza does not represent an unmet medical need in the Indian healthcare context
The committee has instructed Roche to submit a detailed Phase III clinical trial protocol for CDSCO review, emphasizing the importance of generating population-specific safety and efficacy data before considering market authorization.
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