- NRx Pharmaceuticals Inc (NASDAQ:NRXP) has filed a new Breakthrough Therapy designation request with the FDA for Zyesami focused on a subgroup of critical COVID-19 patients.
- The subgroup includes patients who were also treated with Gilead Sciences Inc's (NASDAQ:GILD) Veklury (remdesivir) in addition to aviptadil or placebo.
- The request includes safety data on approximately 750 patients treated with intravenous Zyesami for Critical COVID-19.
- NRx Pharmaceuticals submitted a Breakthrough Therapy designation request in 2021, which the FDA did not grant.
- In its reply, the FDA requested new clinical evidence comparing the safety and efficacy of aviptadil relative to other existing therapies.
- NRx Pharmaceuticals performed a post-hoc analysis of its completed Phase 2b/3 study focused on approximately 70% of patients based on the FDA's input.
- Read Next: NRx Pharma Says I-SPY Study Of Inhaled Zyesami In Critical COVID-19 Stopped.
- Zyesami showed a highly significant four-fold increased odds of survival compared to placebo at 60 days (P=.006).
- In February, NRx Pharmaceuticals submitted a new Emergency Use Authorization request focused on this narrower patient population.
- Price Action: NRXP shares are down 7.28% at $1.98 during the market session on the last check Thursday.
