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Zydus Cadila needs approval for antibody cocktail human trial

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Reuters    27 May 2021

India is continuously wrestling with a shortage of medicines and vaccines to effectively manage a devastating 2nd wave of the coronavirus pandemic. Indias Zydus Cadila has sought regulatory approval for its antibody cocktail clinical trials to treat mild COVID-19 infection.

The treatment candidate is ZRC-3308 and it has earlier shown to decrease lung damage during animal trials. The drugmaker stated that addition of it was safe and well-tolerated. The treatment is a cocktail of two monoclonal antibodies mimicking the natural antibodies the body generates to fight any infection.

Sharvil Patel, Zydus Cadilas managing director, said that at this junction, a critical need is necessary to explore safe and more effective treatments to fight against COVID-19. The company is trying to seek permission for conducting early-to-late-stage human clinical trials from the Drugs Controller General of India.

The U.S. Food and Drug Administration has already given emergency use authorizations to similar therapies that were developed by Vir Biotechnology and Glaxo Smith Kline and by Regeneron Pharmaceuticals and Eli Lilly.

Regeneron and Roches antibody cocktail had got the emergency use approval in India and will be circulated by Cipla. The first batch of the cocktail was made available earlier this week.

On Wednesday, Indias total coronavirus cases has crossed 27 million, with 208,921 fresh cases reported in the last 24 hours. The daily death toll from COVID-19 rose by 4,157.

Source: ET Healthworld

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