SABIZABULIN ( NUEVO TRATAMIENTO ORAL COVID19 ) de la Farmacéutica Veru ... Tiene Ya el Status de Fast Track y el PRÓXIMO 10 de Mayo la FDA lo Podría Aprobar Vía Uso de Emergencia en EEUU .

 

Florida-Based Veru Inc. Today Announced That The U.S. FDA Granted The Company a Pre-Emergency Use Authorization (EUA) Meeting Regarding The Positive Phase III COVID19 Study Results For SABIZABULIN . 

Treatment With SABIZABULIN 9mg Once Daily, an Oral Pill , First-in-Class, New Chemical Entity, cytoskeleton disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55% relative reduction in deaths.

The FDA meeting is scheduled for May 10, 2022.

The double-blind, randomized, placebo-controlled Phase III COVID-19 clinical trial was conducted in approximately 210 hospitalized COVID-19 patients with moderate to severe COVID. Based on a planned interim analysis of the first 150 patients to complete 60 days of follow-up, the Independent Data Monitoring Committee unanimously halted the study for overwhelming efficacy and safety.

“We appreciate FDA’s actions to expedite this process as COVID-19 cases are on the rise again,” said Mitchell S. Steiner MD, Chairman, President, and CEO of Veru Inc., in a press release issued on May 2, 2022.

The FDA previously granted Fast Track designation to the Company’s COVID-19 program in January 2022.

“Sabizabulin es el Primer Fármaco Oral Que Demuestra una Reducción Clínica y Estadísticamente Significativa de las Muertes en Pacientes Hospitalizados”, Dijo el Dr. Mitchell Steiner, Director Ejecutivo de Veru .

¡¡¡ Esto Representa un Gran Paso Adelante !!! .