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).
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.