Sanofi's and Regeneron Pharmaceuticals’ rheumatoid arthritis (RA) biologic Kevzara™ (sarilumab) achieved its first approval by Health Canada. Clearance covers use of the interleukin-6 receptor (IL-6R)-targeting monoclonal antibody (mAb) for treating moderately to severely active RA in adult patients who have either not responded adequately or who are intolerant to one or more biologic or no biologic disease-modifying antirheumatic drugs (DMARDs).
A decision on sarilumab by the European Medicines Agency is anticipated this year, and resubmission of the sarilumab BLA to the FDA is expected during Q1 2017, following moves by Sanofi to correct issues at its Le Trait facility, where sarilumab is filled and finished. The sarilumab BLA was originally accepted by the FDA in January 2016, with a PDUFA target date of October 30th. However, rather than the drug winning the agency's approval, the firms received a Complete Response Letter at the end of October citing what FDA termed deficiencies at the Le Trait facility, which were identified during a routine GMP inspection.
Kevzara will be marketed in Canada by Sanofi Genzyme. Approval was based on data from the global, 2900-patient SARIL-RA program of pivotal studies evaluating sarilumab either alone, or in combination with conventional DMARDs, in patients with moderately to severely active RA who had an inadequate response to previous treatment regimens.
Roche’s IL-6R-targeting biologic Actemra®/RoActemra (tocilizumab) was the first anti-IL-6R biologic to be approved for treating RA, back in 2010, and achieved sales of CHF 1.7 billion (about $1.7 billion) in 2016, a 16% increase on 2015 sales. Sanofi and Regeneron have also positioned sarilumab to compete directly against Abbvie’s anti-tumor necrosis factor (TNF) antibody Humira® (adalimumab), which achieved global sales of $16.1 billion in 2016, also up 16% on 2015 sales. In November 2016, Sanofi and Regeneron reported data from the Phase III SARIL-RA-MONARCH study in 369 patients, which showed that sarilumab montherapy was more effective than Humira in improving the clinical signs and symptoms of active RA in adults.
“Regeneron and Sanofi look forward to resubmitting the U.S. BLA for Kevzara later this quarter and anticipate a new U.S. action date in the second quarter of 2017,” said Robert Terifay, evp, Commercial, Regeneron. “We are especially grateful for the commitment of the patients and investigators who participated in our SARIL-RA clinical program and have helped to bring this important new therapy to RA patients.”
Earlier this month, U.K. biotech Tiziana Life Sciences negotiated an exclusive license to Novimmune’s fully human IL-6R monoclonal antibody NI-1201, which the firm claims demonstrates a unique mechanism of action compared with other IL-6R MAbs, such as tocilizumab.