No efficacy data of Regdanvimab on COVID variants in India: CDSCO panel rejects Abbott proposal
New Delhi: In a major setback to Abbott Healthcare, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has rejected granting emergency approval for Regdanvimab Concentrate for solution for infusion vial 960 mg/16 mL (strength 60 mg/ml) to treat Covid 19, citing that there is no efficacy data of the drug on the COVID variants prevalent in India.
This recommendation came in the wake of the proposal presented by the drug-maker Abbott Healthcare for marketing authorization of Regdanvimab Concentrate for solution for infusion vial 960 mg/16 ml (strength 60 mg/ml) based on waiver of local (Phase III & Phase IV) trial in the country.
Regdanvimab is a monoclonal antibody that is being researched to treat coronavirus disease 2019 (COVID19).
Regdanvimab binds to the spike protein of the SARS-CoV-2 virus, which causes COVID-19. When it binds to the spike protein, the virus's ability to enter the body's cells is hampered. In individuals with mild to moderate COVID-19, this is intended to reduce the requirement for hospitalisation.
The committee at its 178th SEC meeting to examine COVID-19 related proposals under the accelerated approval process held on 26.08.2021 and 27.08.2021 at CDSCO, thoroughly examined Abbott Healthcare's proposal for marketing authorization of Regdanvimab Concentrate for solution for infusion vial 960 mg/16 ml (strength 60 mg/ml) based on waiver of local (Phase III & Phase IV) trials in the country.
The committee noted that the drug is approved only in South Korea and there is no efficacy data of the drug on the COVID variants prevalent in India. Furthermore, the committee observed that there is no safety and efficacy data in the Indian population for the medicine Regdanvimab.
After detailed deliberation, the committee did not recommend the grant of emergency approval of the drug.
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