With reference to Baloxavir Marboxil, consider the following statements:
1. It inhibits the neuraminidase enzyme of the influenza virus.
2. It was rejected for marketing in India because the drug failed efficacy trials abroad.
3. The CDSCO’s Subject Expert Committee mandated Phase III trials in the Indian population.
Which of the statements given above is/are correct?

Question

Accepted Answer

3 only — Statement 1 is incorrect because Baloxavir Marboxil is a cap-dependent endonuclease inhibitor targeting the polymerase acidic (PA) protein, not a neuraminidase inhibitor. Statement 2 is incorrect because the drug is already approved in the US, Japan, Canada, and Australia; the rejection was specifically of the trial waiver request, not of the drug itself. Statement 3 is correct as the SEC mandated local Phase III trials before granting marketing approval in India.

CDSCO Mandates Phase III Trial for Baloxavir

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