Kevzara launched in the United States
In May 2017, the FDA approved Regeneron Pharmaceuticals’ (REGN) and Sanofi’s (SNY) Kevzara for the treatment of adult individuals with moderately to severely active rheumatoid arthritis (or RA) who had had inadequate responses or who were intolerant to one or more disease-modifying anti-rheumatic drugs (or DMARDs).
Kevzara has been approved for use as a monotherapy as well as in combination with methotrexate or any other standard DMARDs.
The FDA’s approval of Kevzara was based on the pivotal Phase 3 MOBILITY and TARGET clinical trials, which were undertaken to evaluate the safety and efficacy of Kevzara in the treatment of RA patients.
The Phase 3 MOBILITY trial evaluated the safety and efficacy of Kevzara in combination with methotrexate (MTX) compared to a placebo and MTX combination therapy. The MOBILITY trial demonstrated a significant reduction in the symptoms of RA, along with an improvement in physical functions. It also showed substantially less radiographic progression of structural damage in patients under Kevzara plus MTX therapy compared to patients on the placebo and MTX therapy.
The primary endpoint of the study was to achieve a reduction in signs and symptoms measured by the proportion of patients who accomplished a 20% improvement according to the American College of Rheumatology Criteria (or ACR20). At 24 weeks, 66%, 58%, and 33% of patients taking Kevzara 200mg plus MTX, Kevzara 150mg plus MTX, and the placebo plus MTX, respectively, achieved the primary endpoint.
The determination of the radiographic progression of structural damage was also a key endpoint criterion of the study, which was measured by the change in the modified Total Sharp Score (or mTSS). At 52 weeks, patients taking the placebo and MTX had mTSS of 2.78, compared to patients taking Kevzara 200mg plus MTX and Kevzara 150mg plus MTX, whose scores were 0.25 and 0.90, respectively. The study proved that patients undergoing the Kevzara treatment showed substantially less radiographic progression of structural damage.
The evaluation of physical function, another primary endpoint of the study, was measured by the Health Assessment Questionnaire – Disability Index (HAQ-DI). At 16 weeks, patients under Kevzara 200mg plus MTX and Kevzara 150mg plus MTX had HAQ-DI levels of -0.58 and -0.54, respectively, compared to -0.30 for patients under the placebo plus MTX.
The Phase 3 TARGET trial evaluated the safety and efficacy of Kevzara plus DMARD compared to the placebo plus DMARD. At 24 weeks, 66%, 56% and 34% of patients taking Kevzara 200mg plus DMARD, Kevzara 150 mg plus DMARD, and the placebo plus DMARD, respectively, achieved the ACR20 response. The demonstration of the achievement of ACR20 was a primary endpoint criterion of the study.
At 12 weeks, patients under Kevzara 200mg plus DMARD and Kevzara 150 mg plus DMARD had HAQ-DI levels of -0.49 and -0.50, respectively, compared to the HAQ-DI level of -0.29 for patients taking the placebo plus DMARD therapy.
These promising results in clinical trials could aid in Regeneron’s effective marketing of Kevzara worldwide. However, Kevzara could still face stiff competition from Amgen’s (AMGN) Enbrel, AbbVie’s (ABBV) Humira, Pfizer’s (PFE) Celebrex, and Johnson & Johnson’s Remicade. Notably, the First Trust Mega Cap AlphaDEX ETF (FMK) has ~2.0% of its total portfolio holdings in Regeneron Pharmaceuticals.