AstraZeneca (AZN) - Get Astrazeneca PLC Sponsored ADR Report said Tuesday that it had requested emergency-use authorization from the Food and Drug Administration for its drug to prevent symptomatic Covid.
The U.K. pharmaceutical giant submitted the request for AZD7442, its long-acting antibody combination.
“If granted, AZD7442 would be the first [long-acting antibody combination] to receive [emergency-use authorization] for Covid-19 prevention,” AstraZeneca said.
“It is the first LAAB with Phase III data demonstrating a statistically significant reduction in the risk of developing symptomatic Covid-19 compared to placebo. …
“In August, 2021, AstraZeneca announced high-level results from the Provent pre-exposure prophylaxis trial, which showed AZD7442 reduced the risk of developing symptomatic Covid-19 by 77% … compared to placebo.”
AstraZeneca stock recently traded at $60.10, down 0.7%. The shares have jumped 22% over the past six months.
“Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing Covid-19,” said Mene Pangalos, executive vice president of biopharmaceuticals R&D for Astra.
“With this first global regulatory filing, we are one step closer to providing an additional option to help protect against Covid-19 alongside vaccines. We look forward to sharing AZD7442 data for the treatment of Covid-19 later this year.”
In other Covid news Tuesday, Johnson & Johnson (JNJ) - Get Johnson & Johnson (JNJ) Report said it had submitted a formal request to the FDA for approval of its COVID booster shot for people over 18.
The New Brunswick, N.J., health-care giant last month said that a second shot increased its efficacy to around 94%.