GSK switches to subcutaneous route for antibody
pharmafile | September 16, 2010 | News story | Research and Development | Arzerra, Genmab, GlaxoSmithKline, ofatumumab
GlaxoSmithKline says it will switch development of a new antibody treatment to a subcutaneous injection, to make it more commercially viable and patient-friendly.
The company has been working with Danish biotech company Genmab on its ofatumumab since 2006. The partners launched the drug earlier this year under the brand name Arzerra as a treatment for chronic lymphocytic leukaemia, but are pursuing further indications in autoimmune diseases.
GSK is now overseeing development for autoimmune indications, and has now announced a new strategy for developing ofatumumab.
The company says it will end work on an intravenous formulation and instead develop a subcutaneous delivery of ofatumumab for multiple sclerosis (MS).
This move will help it compete more effectively in the MS market, which will shortly see the launch of two oral treatments for the condition. GSK clearly calculated that an infusion-based treatment would make ofatumumab less attractive for patients and doctors.
It says positive results from a recently announced phase I/II study in multiple sclerosis (MS) means it will now move on to a phase IIb dose ranging study in MS using the subcutaneous form in 2011, following discussions with regulators.
Ofatumumab’s possible use in rheumatoid arthritis (RA) via a subcutaneous administration is also under review.
“Although the intravenous delivery of ofatumumab has previously demonstrated positive results in MS and RA studies, the autoimmune programme is being refocused on the subcutaneous delivery of ofatumumab because GSK believes this route of administration has the potential to offer added convenience and improved tolerability” said GSK’s Ian Tomlinson, senior vice-president of biopharmaceuticals R&D.
Genmab’s chief executive Jan van de Winkel said: “Genmab initiated the early development of ofatumumab in the autoimmune indications and we are pleased and highly supportive of GSK’s continued commitment to the development of ofatumumab in these chronic diseases.”
Ofatumumab is not currently licensed for any autoimmune indications. GSK and Genmab will continue their development of ofatumumab in multiple oncology indications with the intravenous route of administration.
Andrew McConaghie
Related Content
Genmab to submit FDA application for lymphoma therapy
Global biotechnology company Genmab plans to submit a supplemental Biologics License Application (sBLA) to the …
GSK and Vir Biotechnology COVID-19 drug found to reduce deaths and hospitalisation by 85%
Vir Biotechnology and GSK have announced that their monoclonal-antibody drug has been found to reduce …
GSK and CureVac sign £132m deal to develop next-generation COVID-19 vaccine
GlaxoSmithKline (GSK) and CureVac have today announced they are joining forces to develop a new …
