Zealand drug hit with CRL for ul­tra-rare dis­ease amid man­u­fac­tur­ing con­cerns, plans to re­sub­mit in 2024

The FDA re­ject­ed Zealand Phar­ma’s glucagon re­cep­tor ag­o­nist in con­gen­i­tal hy­per­in­sulin­ism (CHI) af­ter iden­ti­fy­ing prob­lems at a third-par­ty man­u­fac­tur­ing site.

The com­pa­ny said it re­mains con­fi­dent that it can re­sub­mit in the first half of 2024.

Zealand re­vealed last week that the reg­u­la­tor is­sued a com­plete re­sponse let­ter in re­sponse to part one of the NDA for dasiglucagon to pre­vent and treat hy­po­glycemia in new­borns sev­en days old or old­er for up to three weeks of dos­ing.

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