Dec 8: Basil, Switzerland-based Roche pharmaceuticals company reports positive results from two international phase III trials of its MabThera – a form of rituximab that can be injected under the skin rather than delivered intravenously.
Rituximab is used to treat illnesses involving overactive or dysfunctional immune B cells, such as lymphomas, and some autoimmune disorders such as RA; and, according to pilot trials may benefit at least a subset of ME/CFS patients. (For background click here.)
The MabThera studies suggest this subcutaneously delivered rituximab, submitted for approval to the European Medicines Agency on Dec 4:
• Requires much less patient time in an infusion center (5 minutes vs. 2-1/2 hours for administration)
• Delivers comparable (“noninferior”) concentrations in the blood vs the IV mode of administration, with similar, mostly mild to moderate adverse event and administration related reactions.
• Based on an exploratory switch from IV to subcutaneous administration, does not appear to compromise proven response rates (in this case anti-lymphoma efficacy).
• And as a ready-to-use formulation should reduce pharmacy and staff preparation and administration time.
Source: Based on Roche press release, Dec 8, 2012. For full details, go to http://www.roche.com/med-cor-2012-12-08b.htm