Zealand Pharma hit with second CRL for glucagon receptor agonist

The FDA hand­ed down a sec­ond com­plete re­sponse let­ter to Zealand Phar­ma for its glucagon re­cep­tor ag­o­nist in an ul­tra-rare ge­net­ic dis­ease called con­gen­i­tal hy­per­in­sulin­ism for pe­di­atric pa­tients.

Ac­cord­ing to Zealand, the CRL for dasiglucagon has to do with a rein­spec­tion of a third-par­ty man­u­fac­tur­ing fa­cil­i­ty. The com­pa­ny said the rein­spec­tion was com­plet­ed in Au­gust or Sep­tem­ber, though the fa­cil­i­ty hasn’t re­ceived its in­spec­tion clas­si­fi­ca­tion yet. It not­ed that the re­jec­tion has noth­ing to do with the safe­ty or clin­i­cal da­ta of the drug.

“We are com­mit­ted to work­ing with the FDA and our third-par­ty man­u­fac­tur­ing part­ner to bring dasiglucagon to pa­tients liv­ing with this dev­as­tat­ing dis­ease in the months ahead,” Zealand CMO David Kendall said in a state­ment.

The FDA re­ject­ed the drug for the first time last De­cem­ber, due to “de­fi­cien­cies iden­ti­fied fol­low­ing an in­spec­tion at a third-par­ty con­tract man­u­fac­tur­ing fa­cil­i­ty.”

Dasiglucagon’s ap­pli­ca­tion has two parts: The first is for dos­ing up to three weeks, and the sec­ond is for dos­ing be­yond three weeks. The CRL im­pacts the first part of the ap­pli­ca­tion. The sec­ond part of the ap­pli­ca­tion is cur­rent­ly un­der­way af­ter the FDA asked Zealand to sub­mit more analy­ses from ex­ist­ing con­tin­u­ous glu­cose mon­i­tor­ing datasets from the Phase 3 tri­al. Zealand said it ex­pects to sub­mit the ad­di­tion­al da­ta by the end of this year.

The drug won FDA ap­proval as Ze­ga­logue in 2021 for se­vere hy­po­glycemia in adults and chil­dren with di­a­betes. Ze­ga­logue is li­censed to No­vo Nordisk, which is re­spon­si­ble for glob­al com­mer­cial­iza­tion.