An FDA mis­take sig­nals like­ly ap­proval for first ther­a­py for chil­dren born with­out a thy­mus

The FDA on Thurs­day ac­ci­den­tal­ly pub­lished a no­tice an­nounc­ing the award of a pri­or­i­ty re­view vouch­er to rare dis­ease drug de­vel­op­er En­zy­vant for its new re­gen­er­a­tive ther­a­py for the treat­ment of pe­di­atric pa­tients with con­gen­i­tal athymia.

The on­ly prob­lem? The treat­ment still hasn’t won FDA ap­proval. The agency told End­points the no­tice was pub­lished in er­ror and will be with­drawn. The re­lease of the PRV no­tice, which typ­i­cal­ly come days or weeks af­ter an ap­proval is an­nounced, puz­zled the com­pa­ny.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER