US approves emergency use of Covid-19 antibody treatment given to Trump

The treatment is a cocktail of two powerful antibodies that have shown promise in early studies at keeping the infection in check.
The treatment is a cocktail of two powerful antibodies that have shown promise in early studies at keeping the infection in check.PHOTO: REUTERS

WASHINGTON • The US Food and Drug Administration (FDA) 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 United States continue to rise.

The treatment, made by the biotech company Regeneron, is a cocktail of two powerful antibodies that target the spike protein used by the virus to enter cells. The treatment has 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.

Mr Trump was treated with the drug based on a compassionate-use request by his doctors.

A similar treatment, made by Eli Lilly, was given emergency approval on Nov 9.

The emergency authorisation for Regeneron's treatment is limited in scope. It is for people 12 and over who have tested positive for the coronavirus and who are at high risk of developing severe Covid-19.

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

With an average of more than 168,000 people diagnosed each day with Covid-19 in the US and hospitals running out of beds in some regions of the country, immediate questions are raised about who will get access to the treatments.

Regeneron has said it will have enough of the drug for only about 80,000 people by the end of the month, 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, a complex and time-consuming process. 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 garnered 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 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 last Friday 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 that 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 last month, 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.

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 last month to supply the government with 300,000 doses.

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.

Early data released by Regeneron suggests 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.

NYTIMES, BLOOMBERG

 
A version of this article appeared in the print edition of The Straits Times on November 23, 2020, with the headline 'US approves emergency use of antibody given to Trump'. Print Edition | Subscribe