Pfizer Inc. scored a $5.29 billion deal with the U.S. government to provide 10 million courses of the company’s oral antiviral candidate Paxlovid (PF-07321332; ritonavir) for COVID-19, as Astrazeneca plc and Novavax Inc. also generated news in the space. Paxlovid, if approved or authorized, would be the first oral antiviral of its kind: a 3CL protease inhibitor specifically designed to combat SARS-CoV-2. New York-based Pfizer is seeking emergency use authorization (EUA) from the FDA. Rolling submissions have also commenced in several other countries, and the company continues to build its case for regulatory agencies around the world.
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.
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.
There’s been a mixed bag of data from Astrazeneca plc’s efforts against COVID-19, after data suggested Pfizer Inc.’s rival vaccine is more effective against the Delta variant and the failure of a trial involving its long-acting antibody therapy.
Astrazeneca plc said it has received about $486 million from the U.S. government to support the development and supply of a long-acting antibody combination under evaluation for the prevention and treatment of COVID-19. Phase III trials of the candidate, AZD-7442, are slated to begin later this month, the company told BioWorld. One trial will enroll more than 6,000 adults for the prevention of COVID-19 with additional trials set to enroll about 4,000 adults for the treatment of the infection, the Cambridge, U.K.-based company said.