THE NEUTRAL ZONE
The Food and Drug Administration Saturday approved emergency use of Regeneron’s antibody drug treatment to boost the immune system of those fighting COVID-19 infections.
The antibody cocktail showed promise in early studies to curb infection, though the authorization is only for patients 12 and older with mild to moderate coronavirus symptoms. The FDA gave emergency approval to Eli Lilly for a similar treatment earlier this month. Regeneron’s synthetic antibody treatment targets the coronavirus’ spike protein, which prevents the virus from attaching to cells.
Regeneron will ship 30,000 doses Tuesday. About 80,000 doses will be available by the end of this month. Regeneron expects to have 300,000 patients treated by the end of January, according to CEO Dr. Leonard Schleifer.
White House spokesman Michael Bars said in a statement, “Due to advancements in quality care, information for medical personnel to better treat patients, and life-saving vaccines rapidly advancing toward approval faster than ever before, the United States has never been more prepared to confront the coronavirus and save millions of lives as we are now.”
President Donald Trump took the drug as part of his treatment for coronavirus when he was hospitalized in October. Ben Carson attested to the drug’s efficacy, saying, “President Trump was following my condition and cleared me for the monoclonal antibody therapy that he had previously received, which I am convinced saved my life.”
The approval comes as the U.S. topped 200,000 news coronavirus cases on Friday, totaling 12 million cases since the beginning of the pandemic. AstraZeneca announced its COVID-19 vaccine showed a 70% effectiveness rate, following similar announcements of over 90% effectiveness from Pfizer and Moderna last week.
Regeneron, following in Lilly’s footsteps, wins FDA emergency nod for COVID-19 antibody cocktail – FiercePharma – 11/23/2020
Regeneron’s COVID-19 antibody cocktail, one of the drugs President Donald Trump was given after he was infected with the SARS-CoV-02 virus, has been cleared for emergency use by the FDA. And, despite looming rollout of vaccines, one analyst still sees the therapy as a steady $1 billion-plus business. The emergency use authorization (EUA) for REGN-COV2, a combination of monoclonal antibodies casirivimab and imdevimab, marks the second for an antibody therapy. The first one went to Eli Lilly’s bamlanivimab, which was given an EUA a few days ago.
Regeneron antibody treatment previously given to Trump receives FDA emergency authorization – Salon – 11/23/2020
REGN-COV2 is similar to a treatment developed by the pharmaceutical company Eli Lilly that was given emergency use authorization earlier this month, according to The New York Times. Regeneron’s drug cocktail will only be allowed for people over 12, have tested positive for SARS-CoV-2 and are at a high risk for developing severe COVID-19. The company only expects to have about 80,000 doses of REGN-COV2 available by the end of November, 200,000 by the first week of January and 300,000 by the final week of January.
Drug Company Will Send Out 300,000 Doses Of The COVID-19 Antibody Treatment Trump Took By January, CEO Says – The Daily Caller – 11/23/2020
Drug company Regeneron will supply 300,000 doses of their newly approved COVID-19 treatment, the company’s CEO, Dr. Leonard Schleifer, told CNBC on Monday. The Food and Drug Administration issued an emergency authorization for the antibody treatment in a news release on Saturday saying that the authorization would provide another tool to combat the pandemic. The experimental treatment was given to President Donald Trump in October after he contracted COVID-19. Trump heralded the treatment, crediting it with his rapid recovery and saying that he felt it was a cure.
Ben Carson Says Cocktail Drug Treatment for COVID-19 ‘Saved His Life’ – The Root – 11/23/2020
Now Carson has revealed that he suffered from an especially serious case of the virus, and in a Facebook post on Friday attributed the fact that he’s still alive to getting special treatment with the help of the president. […] Luckily the cocktail antibody drug Regeneron, which was reported as the treatment Trump received when he was hospitalized last month with COVID-19, was just this weekend granted emergency authorization by the Food and Drug Administration to treat the virus in people 12 and older, reports the Washington Post. The authorization of Regeneron and the finalizing of COVID-19 vaccines from Pfizer and Moderna hopefully means that soon Americans other than those in the Trump orbit will have the benefit of better options for treatment and protection from the novel coronavirus.