NRx Pharmaceuticals has filed a request for ZYESAMI (aviptadil) as BTD To US FDA

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NRx Pharmaceuticals has filed a request for ZYESAMI (aviptadil) to be designated as a Breakthrough Therapy in patients who are at immediate risk of death with COVID-19 despite treatment with Remdesivir and other approved therapies.

The US National Institutes of Health-sponsored trial comparing ZYESAMI and Remdesivir alone and in combination has enrolled more than 350 patients and continues to show safety.

NRx Pharmaceuticals has submitted a new Breakthrough Therapy Designation (BTD) proposal to the US Food and Drug Administration (FDA) for patients with Critical COVID-19 and respiratory failure who are at urgent danger of mortality despite treatment with remdesivir and other approved medicines.

After the FDA requested clinical data for ZYESAMI vs. Remdesivir in these high-risk individuals, NRx filed the request. The new study was undertaken by Prof. David Schoenfeld, one of the world’s most frequently published statisticians with a specialty in life-threatening lung disorders.

NRx Pharmaceuticals believes that with the FDA’s permission, we will be able to help more than 100,000 Americans reunite with their loved ones who would otherwise not live to see next year’s holidays.

In a randomised trial of 196 patients, ZYESAMI (aviptadil) showed a statistically significant two-fold increase in survival relative to placebo across all patients and hospitals investigated. ZYESAMI, on the other hand, showed a highly significant four-fold improved odds of survival at 60 days compared to placebo in 70% of patients who had already been treated with Remdesivir and continued to advance despite all approved medications (P=.006). Furthermore, when compared to placebo, those treated with ZYESAMI after Remdesivir failed have a 3-fold greater chance of being alive and free of respiratory failure at 28 and 60 days (P=.0).

The FDA recently denied ZYESAMI’s application for Emergency Use Authorization (EUA) and Breakthrough Therapy Designation (BTD), but has welcomed a fresh submission based on new clinical evidence that aviptadil could provide a significant improvement in treatment over existing medicines. NRx has tailored their BTD request based on FDA feedback to treat COVID-19 respiratory failure in individuals who have progressed after therapy with remdesivir and other approved treatments.

“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,”

said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals.

Patients whose respiratory failure has advanced despite Remdesivir treatment were the focus of the Breakthrough Therapy Designation request.

The filing is in response to an FDA request for clinical data comparing ZYESAMI to Remdesivir and other authorised treatments.

At day 28 and day 60, patients who received ZYESAMI had a statistically significant (P=.03) 2.8-fold greater chance of being alive and free of respiratory failure compared to those who received placebo. These patients had a four-fold greater chance of surviving (P=.006), which is very significant (P=.006). Patients who were at the highest risk – those who were on ventilators at the time of randomization – had a 10-fold higher chance of surviving (P=.03).

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