Novo’s hemophilia drug, Ionis-AZ’s TTR therapy get CHMP nods

In its October meeting, EMA’s CHMP recommended approval of six new medicines, including a hemophilia A/B therapy from Novo Nordisk, and TTR antisense oligonucleotide for from AstraZeneca and Ionis. It again rebuffed PTC’s Translarna.

After receiving a complete response letter from FDA last year, Alhemo concizumab from Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) took a major step toward European approval with a recommendation from CHMP. The once-daily subcutaneous anti-TFPI mAb under review to prevent bleeding in hemophilia A and B patients on FVIII and FIX inhibitors, respectively. In the CRL, FDA requested additional information on dosing, monitoring and manufacturing. ...