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AstraZeneca asks FDA to authorise COVID antibody remedy

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AstraZeneca, the Anglo-Swedish drugmaker that developed one of many first COVID-19 vaccines, has requested the U.S. Food and Drug Administration to authorise the emergency use of an antibody remedy to forestall the illness.

The firm mentioned Tuesday that the remedy, generally known as AZD7442, could be the primary long-acting antibody mixture to obtain an emergency use authorization for COVID-19 prevention. The remedy could assist defend individuals whose immune programs do not reply adequately to vaccination, AstraZeneca mentioned.

Late-stage human trials confirmed that AZD7442 decreased the chance of creating symptomatic COVID-19 by 77%. More than three-quarters of the individuals had suppressed immune programs and different situations that made them extra prone to extreme illness.

“Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19,” Mene Pangalos, AstraZeneca’s govt vp for pharmaceutical analysis, mentioned in an announcement. “With this primary world regulatory submitting, we’re one step nearer to offering a further choice to assist defend in opposition to COVID-19 alongside vaccines.” U.S. demand for antibody therapies soared over the summer time, significantly in states like Florida, Louisiana and Texas, the place hospitalisations amongst unvaccinated sufferers threatened to overwhelm the well being care system.

The medication are laboratory-made variations of virus-blocking antibodies that assist struggle off infections. The therapies assist the affected person by supplying concentrated doses of 1 or two antibodies.

The fundamental antibody remedy getting used within the U.S. is Regeneron’s dual-antibody cocktail. The FDA has additionally licensed the Regeneron product as safety for high-risk individuals in opposition to extreme COVID-19.

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