GlaxoSmithKline plc (NYSE:GSK) (GSK) revealed on Monday that it has completed the Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA), seeking approval of the subcutaneous formulation of human anti-interleukin (IL) 6 monoclonal antibody sirukumab for the treatment of moderate-to-severe active rheumatoid arthritis (RA).
Specifically, the company hopes for the approval of sirukumab in combination with methotrexate as a treatment for RA patients who have an intolerance to conventional or biologic disease-modifying antirheumatic drugs (DMARDs) and as a monotherapy for RA patients who have problems with methotrexate.
Commercialization of Subcutaneous Formulation of Sirukumab
Paul-Peter Tak, GSK Chief Immunology Officer (CIO) and Senior Vice President (SVP) of Research and Development (R&D) Pipeline, has noted that an approval will help RA patients greatly since they will have the opportunity to obtain a subcutaneous treatment once a month.
The subcutaneous formulation is being applied for approval in two presentations: 1) a single-dose prefilled syringe; and 2) a single-dose auto-injector. The supporting data filed to the EMA are based on a Phase III program that enrolled over 3,000 patients in a total of five studies.
Sirukumab, which belongs to the immuno-inflammatory drug portfolio of GSK, is part of the 40 assets profiled to the company’s shareholders.
The pharmaceutical giant is also planning to submit the same application for approval to the US Food and Drug Administration (FDA) this year. Should both applications be granted the needed approval, the subcutaneous formulation of sirukumab will be commercially available in the US and Europe.
Collaboration with Johnson & Johnson (NYSE:JNJ) through Janssen Biologics
GSK is developing sirukumab in collaboration with Janssen Biologics. It is part of the licensing and co-development agreement signed by both parties in 2011.
Under the terms of the agreement, GSK owns the commercialization rights of sirukumab in Central America, North America, and South America. Meanwhile, Janssen Biologics owns the commercialization rights of the drug in other parts of the world. In terms of global revenue, GSK and Janssen Biologics have agreed to a 50-50 share.
The Phase III clinical development program began in 2012 following the sealing of the deal between the two companies.