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AstraZeneca Shows FDA Enouraging Antiviral Data

06.10.2021 - AstraZeneca has provided the US Food and Drug Administration (FDA) with encouraging study evidence that its antiviral cocktail candidate AZD7442 can prevent Covid-19 infections in vulnerable people, such as those who are unlikely to respond well to vaccines. This followed disappointing results from an earlier study.

The latest tests focused on a subgroup analysis of people who were PCR-negative at baseline and, according to the Anglo-Swedish drugmaker, it showed a relative risk reduction in the mid-70% range. If approved, the long-acting antibody cocktail could be used as a prophylactic.

“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,” Mene Pangalos, executive vice president for biopharmaceuticals R&D at AstraZeneca, said. “With this first global regulatory filing, we are one step closer to providing an additional option to help protect against Covid-19, alongside vaccines.”

If the FDA agrees that the benefits of the antibody cocktail outweigh the risks, the company will then decide whether to file for approval. The drugmaker said it is currently in talks with governments in other countries about supply deals.

Antibody cocktails to treat Covid are gaining in popularity in the US as vaccination rates have hit a brick wall. With infection rates soaring in areas where the vaccination rate is low, the federal government has been providing state governments with antiviral treatments such as those produced by Regeneron and Eli Lilly at no charge.

Due to the run on the products, Washington is having to ration supply, however. Ron DeSantis, Republican governor of Florida, has accused President Joe Biden of deliberately curbing the state’s volumes as the two are in a clinch over mask-wearing rules. Recently published figures are said to have shown that the state has having received quantities of antivirals out of proportion to its population.

If approved near term, the AZ product – provided that real time results match trial results – could be a welcome antiviral alternative to the after-the-fact treatments.

Whether or when the company’s Vaxzevria Covid-19 vaccine will be greenlighted by the FDA is still up in the air. In 2020, AstraZeneca received $ 1.2 billion in government funding for clinical trials and potential production facilities. The US also ordered 300 million doses, but has donated all that have been produced up to now.

Author: Dede Williams, Freelance Journalist