Please login to the form below

Not currently logged in
Email:
Password:

GSK refocuses MS drug development

GlaxoSmithKline has decided to refocus development efforts for MS drug ofatumumab on an injectable rather than an intravenous formulation

GlaxoSmithKline (GSK) has decided to refocus development efforts for ofatumumab, a human monoclonal antibody being tested for multiple sclerosis (MS) and other autoimmune indications, on an injectable rather than an intravenous formulation. This is in order to maximise convenience and tolerability for patients.

GSK and the Danish firm Genmab restructured their collaborative agreement for the drug this summer in order to give GSK development responsibility for autoimmune indications. Following that change, GSK reviewed the development strategy and determined that it should focus on the subcutaneous delivery of ofatumumab in autoimmune indications.

GSK said it will stop development of the intravenous version in autoimmune disease in spite of clinical data showing efficacy for the formulation in MS and rheumatoid arthritis.

Earlier this month, the companies released positive phase I/II study data for ofatumumab in MS. GSK plans to begin a phase IIb dose ranging study in MS using the subcutaneous formulation next year. Further development of the subcutaneous drug in rheumatoid arthritis is under review, the company said.

The two companies continue to be jointly responsible for the development of an intravenous formulation of the product for oncology indications. A phase II trial of ofatumumab in combination with bendamustine in patients with indolent B-cell non-Hodgkin's lymphoma was initiated in early September.

16th September 2010

Share

Subscribe to our email news alerts

Featured jobs

PMHub

Add my company
Cuttsy + Cuttsy

How do you understand what patients really need, without actually living their lives? How do you walk in someone else’s...

Latest intelligence

The Evolving Role of the Sales Rep
The COVID-19 pandemic sparked an evolution in physician engagement. Jill Padgett, EdD, Head of Training, explores what this means for the sales force and shares her advice for succeeding in...
Measure your omnichannel maturity with our new tool
Try our Omnichannel Maturity Tool to gain tangible advice and an instant analysis of your omnichannel readiness....
Report: Omnichannel advice for the life science industry
In the latest issue of Delta magazine, Fishawack Health's Medical, Marketing, and Consulting experts share their practical advice for creating meaningful omnichannel stakeholder experiences and reveal our proprietary tool for...