GSK Submits RA Drug for European ApprovalBy
GlaxoSmithKline (GSK) has submitted a marketing authorization application (MAA) to the European Medicines Agency seeking approval for the subcutaneous formulation of sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody for treating adult patients with moderate-to-severe active rheumatoid arthritis (RA). The MAA seeks approval for sirukumab in combination with methotrexate in RA patients who have failed or are intolerant to conventional or biologic disease-modifying antirheumatic drugs and as a monotherapy in these patients for whom treatment with methotrexate is inappropriate. Sirukumab is being co-developed for RA as part of a collaboration with Janssen Biologics, part of Johnson & Johnson.
Sirukumab is an investigational human monoclonal immunoglobulin G1 (IgG1) kappa antibody that selectively binds with high affinity to the IL-6 cytokine, a naturally occurring protein that plays a role in autoimmune conditions. GSK is seeking approval for the subcutaneous formulation of sirukumab in two presentations: a single-dose prefilled syringe and a single-dose autoinjector.
A regulatory submission to the US Food and Drug Administration is also planned for 2016. Sirukumab is currently not approved as a treatment for any indication anywhere in the world.
In December 2011, GSK and Janssen entered into a licensing and co-development agreement with respect to sirukumab. Under the terms, GSK has exclusive rights to commercialize sirukumab in North, Central, and South America while Janssen retains commercialization rights in the rest of the world, including Europe. Global profit will be shared equally between the two companies. Prior to the agreement, Janssen had been developing sirukumab for RA.
As part of the collaboration, a Phase III program began in August 2012 to investigate sirukumab for the treatment of moderate-to-severe active RA. Janssen is responsible for the EMA regulatory file.The agreement gives both companies the option to investigate sirukumab for other indications beyond RA. An ongoing Phase III study, announced in November 2015, is currently investigating sirukumab in giant cell arteritis. In addition, there are plans to start a Phase II study for asthma in 2016.