REGEN-COV Archives - Medical Design Sourcing

Regeneron readies new COVID-19 monoclonal antibodies after the emergence of Omicron

Regeneron Pharmaceuticals (NSDQ REGN) plans to develop antibodies that hold up to the Omicron SARS-CoV-2 variant. Lab results from German researchers indicate that the company’s REGEN-COV/Ronapreve (casirivimab and imdevimab) antibody cocktail lost potency against the variant.

REGN shares fell almost 4% to $631.74 today.

“Our antibody cocktail works against Delta. Delta is still surging,” said Dr. Len Schleifer, CEO of Regeneron, in an interview with CNBC. “But if Omicron starts to surge, we need antibodies that work against Omicron.”

The company has a “whole host” of antibodies in its pipeline that could work against Omicron and Delta.

WHO has reported that Omicron is spreading faster than earlier strains when they first emerged.

The variant makes up roughly 3% of U.S. cases at present.

REGEN-COV cuts viral load within 7 days in COVID-19 patients

Regeneron Pharmaceuticals (NSDQ:REGN) and Roche (OTCQX: RHHBY) are touting positive results from a Phase 2/3 study investigating the potential of REGEN-COV (casirivimab and imdevimab) antibody cocktail in hospitalized COVID-19 patients. The study met its primary endpoint of reducing viral load within one week in seronegative patients needing low-flow or no supplemental oxygen.

REGEN-COV, known as Ronapreve outside of the U.S., led to a 36% reduced risk of death by day 29 in the overall treatment population.

“These new results, combined with the nearly 10,000-patient RECOVERY trial, further validate how REGEN-COV can change the course of illness for patients even after they are hospitalized with COVID-19,” said Dr. George D. Yancopoulos, president and chief scientific officer at Regeneron, in a statement.

Roche has partnered with Regeneron (NSDQ: REGN) to help manufacture and distribute REGN-COV2, which Regeneron first developed.

Roche’s chief medi…

DeSantis sets plan for Regeneron monoclonal antibodies to fight COVID-19

Battling its worst surge in COVID-19 cases, Florida has announced it will use Regeneron’s (NSDQ:REGN) REGEN-COV to protect its population.

Florida Governor Ron DeSantis announced that the state would dispense the monoclonal antibody cocktail through mobile clinics and a rapid response unit in Jacksonville. DeSantis stressed that high-risk individuals, including the elderly, along with people with chronic illness and weak immune systems, should obtain the treatment as soon as they develop symptoms.

DeSantis also said the state would use “strike teams” to deploy the monoclonal antibody in nursing homes.

“We are going to bring a lot more Regeneron into Florida, which I think is important,” DeSantis said in an announcement. “This is the most effective treatment that we’ve yet encountered for people who are infected with COVID-19.”

Clinical trials have demonstrated that the drug is effective at reducing hospitalizations and severe illness stemming from…

REGEN-COV lowers risk of symptomatic COVID-19 infections by 81% in study

Regeneron’s (NSDQ:REGN) REGEN-COV remains one of the most effective monoclonal antibody therapies in reducing the risk of serious COVID-19 infections and resulting hospitalizations and deaths. A study recently published in the New England Journal of Medicine found that the drug effectively prevented COVID-19 disease in household contacts of individuals infected with the novel coronavirus.

When delivered subcutaneously, REGEN-COV was 81.4% effective at reducing the risk of symptomatic infections and led to a 92.6% reduction of symptomatic infections after the first week.

Consisting of the monoclonal antibodies casirivimab and imdevimab, REGEN-COV also appeared to accelerate the recovery of COVID-19-infected individuals. In recipients who received the drug, symptoms resolved two weeks faster than in placebo recipients.

Study investigators also found that the drug was generally well-tolerated.

“This peer-reviewed NEJM publication demonstrates that RE…

FDA authorizes lower dose of REGEN-COV COVID-19 antibody cocktail

Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200 mg of Imdevimab.

The initial EUA for REGEN-COV did not include the option for a subcutaneous dose of the antibody cocktail. The option to make the product available via injection makes it easier for doctors or nurses to administer. The use of SARS-CoV-2 monoclonal antibodies has lagged behind vaccines, with only a fraction of eligible patients receiving such antibodies in the past year.

FDA came to its decision after reviewing data from a pivotal Phase 3 study that showed that the drug reduced the risk of hospitalization or death by 70%. The efficacy of the reduced dose is similar to the 2,400 mg dose.

REGEN-COV appears to be …