The US Food and Drug Administration (FDA) has denied emergency use authorization (EUA) to NRx Pharmaceuticals’ Zyesami (aviptadil) for the treatment of critical Covid-19 patients with respiratory failure. The agency cited inadequate data on the known and possible risk-benefit profile of the therapy in people with critical Covid-19 and respiratory failure. The agency said that to date, it had assessed the safety data of only 131 randomised participants receiving the investigational therapy. NRx said it will seek to share data from at least 150 additional patients treated on the NIH ACTIV-3b trial, and that it has requested a Type A meeting with the FDA to discuss Zyesami’s development.
AstraZeneca will not pursue marketing authorisation for its Covid-19 vaccine in Switzerland. The company attributed the move to medical regulator Swissmedic’s insistence on limiting the usage of the vaccine to individuals aged 50 years and above. In October last year, AstraZeneca started rolling submissions to obtain authorisation for the shot in the country, submitting trial data and other required documents. The vaccine was found to have an encouraging reactogenicity profile and was well tolerated in people aged 18 years and above.
Novavax has concluded the rolling submission process for emergency use listing of its Covid-19 vaccine candidate, NVX-CoV2373, with the World Health Organization. The company submitted all the required modules including the chemistry, manufacturing and controls data needed by the agency to review the recombinant nanoparticle protein-based vaccine with Matrix-M adjuvant. Data from the Phase III PREVENT-19 trial in the US and Mexico are included in the filing. The vaccine was found to provide complete protection against moderate and severe Covid-19 in the trial.