Sanofi's sleep­ing sick­ness drug wins FDA OK and a lu­cra­tive pri­or­i­ty re­view vouch­er too

The FDA on Tues­day ap­proved the first oral treat­ment for sleep­ing sick­ness (hu­man African try­panoso­mi­a­sis) from Sanofi and the Drugs for Ne­glect­ed Dis­eases ini­tia­tive, and pro­vid­ed the part­ners with a pri­or­i­ty re­view vouch­er that they may sell for about $100 mil­lion.

Sleep­ing sick­ness is a par­a­sitic dis­ease that’s trans­mit­ted through be­ing bit­ten by tsetse flies and af­fects peo­ple liv­ing in re­mote, sub-Sa­ha­ran Africa, which puts about 65 mil­lion peo­ple at risk of in­fec­tion. But Sanofi has been able to dras­ti­cal­ly re­duce the num­ber of sleep­ing sick­ness cas­es in sub-Sa­ha­ran Africa by about 97% from 2001 and 2020, and fex­inida­zole, its oral-on­ly drug, of­fers an ad­van­tage over oth­er sleep­ing sick­ness treat­ments that re­quire in­fu­sions or in­jec­tions, and which are chal­leng­ing to ad­min­is­ter to pa­tients in re­mote parts of Africa.

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