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 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 a 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.
(With agency inputs)