US Food and Drug Administration grants emergency approval of Regeneron treatment for Covid-19

WASHINGTON (NYTIMES) – The Food and Drug Administration has granted emergency authorisation for the experimental antibody treatment given to President Donald Trump shortly after he was diagnosed with Covid-19, giving doctors another option to treat Covid-19 patients as cases across the country continue to rise.

The treatment, made by the biotech company Regeneron, is a cocktail of two powerful antibodies that have shown promise in early studies at keeping the infection in check, reducing medical visits in patients who get the drug early in the course of their disease.

A similar treatment, made by Eli Lilly, was given emergency approval earlier this month.

The emergency authorisation for Regeneron’s drug is limited in scope: It is for people who have tested positive for the coronavirus and who are at high risk for developing severe Covid-19. Evidence so far suggests that antibody treatments work best early in the course of the disease, before the virus has gained a foothold in the body.

Like Eli Lilly’s treatment, Regeneron’s is not authorised for use in people who are hospitalised or who need oxygen.

The emergency authorisation raises immediate questions about who will get access to the treatments as an average of more than 168,000 people are diagnosed each day with Covid-19 in the United States and hospitals are running out of beds in some regions of the country.

Regeneron has said it will have enough of the drug for only about 80,000 people by the end of November, enough for 200,000 patients by the first week of January, and 300,000 by the end of January. After that, the company said, it will be able to ramp up production thanks to a partnership with Swiss manufacturer Roche.

Regeneron has received more than US$500 million (S$672 million) from the federal government to develop and manufacture the treatments. Although the first 300,000 doses will be provided free, patients may be charged for having the treatment administered; it must be infused in a clinic or hospital.

Antibody treatments have received less attention than vaccines, but health officials have long held out hope that they may serve as a possible bridge until a coronavirus vaccine is more broadly available.

Two vaccines, one made by Pfizer and BioNTech and another by Moderna, were recently shown to be more than 90 per cent effective in early analyses.

Pfizer, which has completed its trial, submitted an application on Friday (Nov 20) for emergency authorisation of the vaccine, and Moderna said it planned to apply soon. Still, it will be weeks before a vaccine is available, and even then, access will be limited to people in high-risk groups.

Dr George Yancopoulos, Regeneron’s president and chief scientific officer, said in a statement he was encouraged by the recent vaccine results but that “there remains a need to treat patients who develop Covid-19, especially as some may not have had access to or were not protected by vaccination”.

Regeneron enjoyed a burst of publicity in October, when Mr Trump received an infusion of its cocktail and then enthusiastically promoted the drug as lending him a superpower-like feeling. In a video released on Oct 7, the president claimed without evidence that it had cured him and that he had authorised it – something he does not have the power to do.

It remains impossible to know whether the Regeneron treatment helped Mr Trump. He was given multiple drugs while at Walter Reed National Military Medical Centre, and many people recover from the virus on their own.

Since the spring, White House and health officials have been closely watching the development of the antibody treatments. In addition to Regeneron’s deal with the federal government, Eli Lilly announced a US$375,000 deal in October to supply the government with 300,000 doses.

A similar antibody treatment that Regeneron developed to fight Ebola was approved by the FDA in October, bolstering confidence that its Covid-19 version would prevail in the ongoing trials of outpatients.

The president and two of his top advisers – White House Chief of Staff Mark Meadows and Mr Trump’s son-in-law Jared Kushner – have called Dr Stephen Hahn, the FDA commissioner, to press for speed in agency reviews.

And Dr Leonard Schleifer, the billionaire co-founder and chief executive of Regeneron, who has known Mr Trump casually for years, has told associates that Mr Trump calls him to ask about the status of the treatment.

Early data released by Regeneron suggest that its cocktail works best in people who do not appear to be mounting an early immune response to the virus, or who have high levels of the virus, and who are therefore at greater risk of faring poorly.