CHMP backs Orphan candidates, PD-1 mAbs

On Friday, EMA's CHMP recommended approval of several candidates, including Orphan disease therapies Isqette dinutuximab beta (APN311) from Apeiron Biologics AG (Vienna, Austria) and Refixia nonacog beta pegol from Novo Nordisk A/S (CSE:NVO; NYSE:NVO). It also recommended label expansions for PD-1 inhibitors Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) and Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY).

The committee recommended Isqette's approval to treat high-risk neuroblastoma under EMA's exceptional circumstances clause. It is recommended for patients aged 12 months and older who achieved a partial response after induction chemotherapy, followed by myeloablative therapy and stem cell transplantation. It is also recommended for patients with relapsed or refractory neuroblastoma. In October 2016, Apeiron granted EUSA Pharma Ltd. (Hemel Hempstead, U.K.) exclusive, worldwide rights to commercialize the chimeric mAb against ganglioside GD2 (GD2)...