Genmab's sBLA for Arzerra approved by FDA

The US Food and Drug Administration has approved a supplemental Biologics License Application (sBLA) for Genmab’s (OMX: GEN) Arzerra (ofatumumab).

The approval is for the use of ofatumumab in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). The application, which received Priority Review in May 2016, was submitted to the FDA by Novartis under the ofatumumab collaboration between Novartis and Genmab. First-half 2016 net sales of Arzerra by Novartis were $24.8 million a decrease of 22%. Sales were negatively impacted by increased competition, primarily from Imbruvica (ibrutinib).

Notwithstanding the positive news from the FDA, Genmab’s share declined 2.19% to 1,071 euros by mid-afternoon trading today.