LONDON – A suite of papers rushed through peer review and published in Nature late on Dec. 23, 2021 contain data indicating approved monoclonal antibody drugs designed to neutralize SARS-COV-2 have substantially weaker activity against the Omicron variant.
The FDA went from zero to two oral antivirals to treat COVID-19 in the space of two days, granting emergency use authorizations last week to Pfizer Inc.’s Paxlovid and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s molnupiravir. Both five-day regimens are authorized for use, within five days of COVID-19 symptom onset, in individuals at high risk of progressing to severe disease, including hospitalization and death.
Although Pfizer Inc.’s COVID-19 oral antiviral candidate, Paxlovid (PF-07321332; ritonavir), has yet to be authorized anywhere, the push for compulsory licensing of the drug has begun.
New positive phase III study results for Regeneron Pharmaceuticals Inc.’s COVID-19 monoclonal antibody cocktail show a single dose reduced the risk of contracting the virus by 81.6% during a two- to eight-month follow-up period. The strong data go along with Pfizer Inc.’s recent positive results for its oral antiviral, Paxlovid, hinting that COVID-19 therapeutics could begin cutting into powerful mRNA vaccine margins from Pfizer Inc.-Biontech SE and Moderna Inc.
Cambridge, U.K.-based Astrazeneca plc has new data from its long-acting COVID-19 antibody combination, AZD-7442, which aims to provide longer protection, potentially for up to a year. Latest data show the intramuscularly injected drug achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild to moderate symptomatic disease.
New data on the COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), already used to treat non-hospitalized patients in multiple countries, could potentially support expanding its use to certain recently hospitalized patients with the disease.
While much of the global pandemic response has focused on vaccines, the World Health Organization is now calling on drug manufacturers to ramp up their supply and donations of monoclonal antibodies used to treat COVID-19 infections.
With the U.S. logging more than 4 million new COVID-19 cases in the past few weeks, federal purchasing of antibody cocktails from Regeneron Pharmaceuticals Inc. and Eli Lilly and Co. is continuing to grow. The government has placed orders for $2.94 billion worth of Regeneron's REGEN-COV (casirivimab and imdevimab) and about $330 million of Lilly's etesevimab to complement doses of bamlanivimab it previously purchased. Both antibody combinations, approved under FDA emergency use authorizations (EUAs), have been shown to reduce risk of hospitalization or death from COVID-19.
As many lower and middle-income countries continue to scramble for COVID-19 vaccine doses, which are largely being manufactured in Europe and the U.S., their own regulatory rules may be getting in the way in some instances.
Astrazeneca plc, en route to potentially delivering a new protection against COVID-19 for people inadequately protected by or unable to be vaccinated, has cleared a crucial hurdle with its long-acting combination therapy, AZD-7442, which met the goals of a phase III pre-exposure prophylaxis trial. The U.K.-based pharma’s readout arrived just as Regeneron Pharmaceuticals Inc. announced the MHRA’s conditional marketing authorization for its Roche Holding AG-partnered COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), also known as REGEN-COV.
