Novartis seeks expanded Arzerra use in US
pharmafile | March 11, 2016 | News story | Research and Development | Arzerra, CLL, FDA, Genmab, Novartis
Novartis has submitted a supplemental Biologics License Application (sBLA) to the US FDA for the use of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) as a treatment for chronic lymphocytic leukemia (CLL).
The Swiss-based company is developing Arzerra with Genmab, having acquired the rights to the drug in the multi-billion asset swap with GSK, completed last year.
The application is supported by results of the Phase III study, COMPLEMENT 2 which showed that Arzerra in combination with FC extended median progression free survival by 10.1 months to 28.9 months, compared with patients receiving FC alone.
“The data from the COMPLEMENT 2 study demonstrated the potential of ofatumumab in combination with FC to help patients with relapsed CLL,” says Jan van de Winkel, Genmab’s chief executive. “We are pleased that Novartis has moved forward with a regulatory application for ofatumumab in this indication in the US.”
Arzerra in pemphigus vulgaris
Novartis however, reported this week that it will not advance the clinical programme for Arzerra in the rare skin disease pemphigus vulgaris, announcing that it is terminating a Phase III trial of the drug in this indication, to focus on the monoclonal antibody as a treatment for relapsing multiple sclerosis.
The decision comes just seven months after Novartis paid $300 million upfront for the rights to Arzerra in autoimmune indications from GSK. GSK subsidiary began Phase III trials for Arzerra in pemphigus vulgaris in 2014.
Joel Levy
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