NRx Pharmaceuticals and Hungarian Health Officials Agree for ZYESAMI and BriLife COVID-19 Vaccine Trials
On Thursday, NRx Pharmaceuticals reported the end of high-level meetings in Hungary, which are expected to lead to the use of ZYESAMI (aviptadil) in Hungary and the start of the BriLife COVID-19 vaccine’s pivotal clinical trial (BriLife).
Hungarian Health Officials and NRx Pharmaceuticals Agree on ZYESAMI and BriLife COVID-19 Vaccine Trials. NRx and Hungary Agree on ZYESAMI Emergency Use Regulatory Path. Hungary will be the first European country to participate in the BriLife COVID Vaccine Trial’s Registrational Phase 2b/3.
Hungary will be the first European country to host a clinical trial site for the BriLife COVID-19 vaccine’s registrational phase 2b/3 study. NRx has been asked to submit a paediatric trial protocol, which might involve both injectable and nasal spray administration of the vaccine, in addition to the already-developed trial plan. Senior regulatory and academic medical authorities will lead Hungary’s NRx effort. The BriLife experiment is scheduled to receive regulatory approval by the end of 2021.
“NRx is pleased to partner with Hungary to bring two lifesaving therapies, ZYESAMI and the BriLife COVID-19 vaccine, to people in the Central European region at a time when humanity’s war against COVID is far from over. We are pleased to have a positive and patient-centric working relationship with Hungarian health authorities that we believe will help prevent COVID-19 infection and serve patients who have exhausted all other approved treatments.”said Prof Jonathan Javitt, MD, MPH Chairman and CEO of NRx.
Hungarian health officials have also agreed on a regulatory approach for the Central European region’s Emergency Use of ZYESAMI (aviptadil), which will commence with a compassionate care programme by the end of 2021. The programme is based on the FDA-approved Expanded Access Protocol, which has previously been implemented in the United States. Under this initiative, confirmatory evidence of clinical effect, along with safety and efficacy data, will be submitted in support of an Emergency Use Authorization in Hungary. COVID-19 is resurgent in Europe, as it is in much of the world, with more than 15,000 people infected and more than 200 people dying each day in Hungary.