Monday, 18 October 2021

 

 

 

Regeneron's Covid drug given to Trump clears emergency use in US

Web Admin

Web Admin

5 Dariya News

New York , 22 Nov 2020

The US Food and Drug Administration (FDA) has granted emergency use approval to the Regeneron Pharmaceuticals antibody treatment which was given to President Donald  Trump after he was diagnosed with Covid-19.The emergency use authorisation is for the antibody cocktail casirivimab and imdevimab to be administered together -- also known  as REGN-COV2 or REGEN-COV2 -- for recently diagnosed, mild to moderate Covid-19 in high-risk patients, the FDA said late on Saturday.Regeneron said that it is the first  treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2, the virus responsible for Covid-19.Casirivimab and  imdevimab administered together are authorised for the treatment of mild to moderate Covid-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at  least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at a high risk for progressing to severe Covid-19 and/or hospitalisation.The clinical  evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients  who have not yet mounted their own immune response or who have high viral load, the company said.

"This FDA Emergency Use Authorisation is an important step in the fight against Covid-19, as high-risk patients in the United States will have access to a promising therapy early  in the course of their infection," Leonard Schleifer, President and Chief Executive Officer of Regeneron, said in a statement."The science and technology investments Regeneron  has made over three decades positioned us to move rapidly to invent, study and maximise production of REGEN-COV2. Even with these incredible efforts, demand may exceed  supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need."Production of  monoclonal antibodies is a complex, time- and labour-intensive process that requires deep expertise.Regeneron now expects to have REGEN-COV2 treatment doses ready for  approximately 80,000 patients by the end of November, approximately 2,00,000 patients by the first week of January, and approximately 3,00,000 patients in total by the end of  January 2021.

 

Tags: Coronavirus , COVID 19 , Novel Coronavirus , Fight Against Corona , Corona Virus Updates , Social Distancing , Coronavirus Epidemic , Coronavirus Pandemic , Corona virus threat , Corona Outbreak , New York , Food and Drug Administration , FDA , REGN-COV2 , REGEN-COV2

 

 

related news

 

 

 

Photo Gallery

 

 

Video Gallery

 

 

5 Dariya News RNI Code: PUNMUL/2011/49000
© 2011-2021 | 5 Dariya News | All Rights Reserved
Powered by: CDS PVT LTD