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December 30, 2021updated 07 Jan 2022 6:14am

NRx seeks breakthrough therapy designation for Covid-19 treatment

In a randomised trial, the therapy demonstrated a statistically significant two-fold increased odds of survival.

By Sumanth Kuluru

NRx Pharmaceuticals has filed a new breakthrough therapy designation (BTD) request for its therapy Zyesami (aviptadil) in Covid-19 patients.

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The request filed with the US Food and Drug Administration (FDA) focused on patients who are at immediate risk of death with the disease even after getting treatment with Remdesivir and other therapies that are approved.

The respiratory failure of these Covid-19 patients also progressed after the treatment with Remdesivir.

NRx’s BTD request comes after the FDA sought clinical results on Zyesami vs Remdesivir in patients with high risk.

In a randomised trial, which enrolled 196 patients, the therapy demonstrated a statistically significant two-fold increased odds of survival against placebo across all subjects and hospitals that were studied.

However, Zyesami showed a significant four-fold increased odds of survival in 70% of subjects who received Remdesivir and continued to progress even after all approved therapies.

This progress was observed in patients in the Zyesami arm compared to those who received placebo at 60 days.

Moreover, subjects who received Zyesami after Remdesivir could not demonstrate three-fold increased odds of both alive as well as free of respiratory failure at both 28 and 60 days, as against placebo.

NRx Pharmaceuticals chairman and CEO professor Jonathan Javitt said: “At a time when America is entering a new Covid-related crisis, we thank the FDA for encouraging us to address the subset of patients who have no other approved treatment.

“More than 2,000 Americans died from Covid-19 on Christmas eve. With the FDA’s support, we believe we have the chance to help more than 100,000 Americans return to their loved ones who otherwise might not live to see next year’s holidays.”

In November this year, the FDA denied granting of emergency use authorization (EUA) and BTD for the company’s Zyesami for the treatment of critical Covid-19 patients with respiratory failure.

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Free Whitepaper
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What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

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