Conduct Phase III CT in Indian population: CDSCO Panel tells Roche Products India on Baloxavir marboxil

New Delhi: Noting that the Indian patient’s clinical data is not sufficient and acute uncomplicated influenza is not an unmet medical need, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined Roche Products (India) to conduct the Phase III clinical trial of the antiviral medication Baloxavir marboxil in the Indian population.

This came after the firm presented the re-deliberation proposal for the grant of permission to import and market Baloxavir Marboxil Tablets [20 mg, 40 mg, and 80 mg] along with justification for the waiver of the Phase III clinical trial before the committee.

Baloxavir marboxil is in a class of medications called polymerase acidic endonuclease inhibitors. It works by stopping the spread of the flu virus in the body.

Baloxavir marboxil, Endonuclease, by binding to the host RNA polymerase (Pol II segment) with the help of PB2 subunit cleaves 10–13 capped RNA fragments from pre-mRNA/mRNA that acts as a primer for generation of 7-methyguanosine capped mRNA from viral RNA (Cap Snatching mechanism).

Baloxavir marboxil is used to treat some types of influenza infection ('flu') in adults and children 5 years and older who have had symptoms of the flu for no longer than 2 days and who are otherwise healthy or are at high risk for developing influenza-related complications.

The expert panel noted that the firm presented data on the prevalence of influenza disease and global clinical trial data. The committee further noted that the Indian patient’s clinical data is not sufficient and acute uncomplicated influenza is not an unmet medical need.

In addition, the drug is approved in countries like the US, Japan, Canada, and Australia.

At the recent SEC meeting for antimicrobial and antiviral held on 13th and 14th February 2025, the expert panel reviewed the re-deliberation proposal for grant of permission to import and market Baloxavir Marboxil Tablets [20 mg, 40 mg, & 80 mg] along with justification for the waiver of the Phase III clinical trial before the committee.

After detailed deliberation, the committee recommended conducting a Phase III clinical trial in the Indian population for the proposed indication.

Accordingly, the expert panel suggested that the firm should submit the Phase III clinical trial protocol to CDSCO for further review by the committee.

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