A COVID-19 antibody therapy used to treat President Donald Trump was approved by the US drug regulator on Saturday for people who aren't yet hospitalized by the disease but are at high risk.
The green light for drug maker Regeneron came after REGEN-COV2, a combination of two lab-made antibodies, was shown to reduce COVID-19-related hospitalizations or emergency room visits in patients with underlying conditions.
"Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system," said Stephen Hahn, commissioner of the Food and Drug Administration.
Leonard Schleifer, Regeneron's president and CEO, added the move was "an important step in the fight against COVID-19, as high-risk patients in the United States would have access to a promising therapy early in the course of their infection."
Regeneron's antibody treatment is the second synthetic antibody treatment to receive an emergency use approval from the FDA after a similar therapy developed by Eli Lilly was granted the status on Nov. 9.
Global access emphasized
G20 nations emphasized the need for global access to coronavirus vaccines at a Saudi-hosted virtual summit Saturday dominated by efforts to tackle the pandemic and the worst global recession in decades.
World leaders, including US President Donald Trump who is refusing to concede a bitter election, popped up in multiple windows across a flickering screen, in a high-stakes webinar held amid the raging pandemic.
The leaders are huddling online for the two-day gathering as international efforts intensify for a large-scale rollout of coronavirus vaccines after a breakthrough in trials, and as calls grow for G20 nations to plug a $4.5-billion funding shortfall.
"Although we are optimistic about the progress made in developing vaccines, therapeutics and diagnostics tools for COVID-19, we must work to create the conditions for affordable and equitable access to these tools for all people," said Saudi King Salman, the summit's host.
Restrictions to be confirmed
British Prime Minister Boris Johnson will confirm that coronavirus lockdown restrictions across England are to end on Dec. 2, his office said Saturday.
The lockdown will be followed by a return to a three-tiered set of regional restrictions as part of the government's "COVID Winter Plan," it added in a statement.
The official announcement is expected to be made on Monday.
The statement quoted a spokesperson for 10 Downing Street as saying that current England-wide restrictions had "helped bring the virus back under control" and "eased pressures on the NHS [National Health Service]".