Date: 2014-05-30
Type of information: Submission of a clinical trial application
phase:
Announcement: submission of clinical trials application
Company: GSK (UK)
Product: subcutaneous formulation of ofatumumab
Action
mechanism: monoclonal antibody
Disease: neuromyelitis optica
Therapeutic area: Rare diseases
Country:
Trial details:
Latest
news: * On March 8, 2016, Genmab announced an update on development plans for ofatumumab in autoimmune indications following the transfer of the rights to ofatumumab in this disease area from GSK to Novartis at the end of 2015. Phase III studies are expected to be initiated by Novartis with the subcutaneous formulation of ofatumumab as therapy for patients with relapsing multiple sclerosis during the second half of 2016. The Phase III study of the subcutaneous formulation of ofatumumab in pemphigus vulgaris, which was started by GSK will be discontinued to focus on relapsing multiple sclerosis. The decision to discontinue the trial was not related to any safety or tolerability concerns. There are no current plans to develop ofatumumab in neuromyelitis optica. * On May 30, 2014, Genmab announced its collaboration partner GSK has taken the decision to start additional pivotal studies with the subcutaneous formulation of ofatumumab. GSK plans to file an IND for a potential pivotal study of subcutaneous ofatumumab in NMO, a rare autoimmune disorder which affects the optic nerve and spinal cord, in 2014. Further details about the NMO program will be available in due course.
