Regeneron Pharmaceuticals Inc.’s (REGN) antibody cocktail REGEN-COV (casirivimab with imdevimab) reduced hospitalization or death by 70% in Non-hospitalized COVID-19 Patients, as per a late-stage trial result. The antibody Cocktail also significantly shortened the duration of symptoms by 4 days.
The phase 3 outcomes trial in high-risk non-hospitalized COVID-19 patients met its primary endpoint, showing the investigational REGEN-COV significantly reduced the risk of hospitalization or death by 70% (1,200 mg intravenous or IV) and 71% (2,400 mg intravenous) compared to placebo.
REGEN-COV also met all secondary endpoints in the Phase 3 outcomes trial, including the ability to reduce symptom duration.
In addition, a companion Phase 2 trial showed that even the lowest doses tested (IV: 300 mg; subcutaneous: 600 mg) had significant viral load reductions over the first 7 study days, comparable to the 2,400 mg and 1,200 mg intravenous doses.
The company stated that it will share new data with regulatory authorities immediately and request that a lower 1,200 mg dose be added to the Emergency Use Authorization.
Regeneron anticipates recording about $260 million in REGEN-COV U.S. net product sales to the U.S. government in the first quarter of 2021, representing final deliveries from the initial agreement with the U.S. government.
Sales under the second U.S. government agreement are now expected to begin in the second quarter of 2021. The company expected to provide about 750,000 doses at the 2,400 mg dose level, but now anticipates being able to provide about 1.25 million doses if the 1,200 mg dose is added to the Emergency Use Authorization.
Due to the pandemic, many organizations are currently utilizing the same limited manufacturing resources including external fill and finish capacity, and this may impact the timing of final delivery of doses. The government is obligated to purchase all finished doses supplied by June 30, 2021, up to 1.25 million doses total, and may accept doses after this date at its discretion.
Roche, which is responsible for REGEN-COV outside the U.S., continues to work with the European Medicines Agency, governments and other health authorities across the globe to bring this antibody cocktail to as many patients as possible.
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