Raul Rodriguez, Rigel CEO

Covid-19 roundup: Tiny sam­ple size leads FDA to turn down Rigel's EUA; Seat­tle biotech to co-de­vel­op mR­NA vac­cine in South Ko­rea

Four months af­ter Rigel an­nounced pos­si­ble Phase II re­sults for its Covid-19 treat­ment, the FDA has deemed the sam­ple size too small and in­suf­fi­cient for an emer­gency use au­tho­riza­tion, the com­pa­ny an­nounced Fri­day.

The Phase II tri­al of fos­ta­ma­tinib, which has pre­vi­ous­ly been ap­proved by the FDA as a sec­ond-line ther­a­py for throm­bo­cy­tope­nia, treat­ed just 59 pa­tients. Right now, a larg­er Phase III tri­al in hos­pi­tal­ized pa­tients is un­der­way to ex­am­ine the ef­fi­ca­cy of fos­ta­ma­tinib in hos­pi­tal­ized pa­tients with mild-to-se­vere Covid-19 com­pli­ca­tions.

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