GlaxoSmithKline and Genmab say that their leukaemia drug Arzerra has demonstrated potential as a treatment for multiple sclerosis in a mid-stage trial.
The Danish biotech has announced top-line results from a Phase II study conducted by GSK of the subcutaneous formulation of Arzerra (ofatumumab) in relapsing-remitting MS. In the randomised trial, which involved 232 patients,CD20 monoclonal antibody significantly reduced the number of new brain lesions over a period of 12 weeks in subjects compared to placebo.
Genmab says there were no unexpected safety findings, adding that to date, “no cases of progressive multifocal leukoencephalopathy or opportunistic infections have been observed”.
The MS data comes days after GSK and Genmab submitted an application to the European Medicines Agency looking to expand the existing approval for Arzerra to allow it to be used as a first-line treatment for chronic lymphocytic leukaemia. The US Food and Drug Administration granted breakthrough therapy designation to the therapy for first-line in September.
