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Regeneron’s Kevzara Approved for Treatment of Rheumatoid Arthritis

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Kevzara approval

In May 2017, the US FDA (Food and Drug Administration) approved Regeneron Pharmaceuticals’ (REGN) and Sanofi’s (SNY) Kevzara (sarilumab) for the treatment of individuals with moderate to severe rheumatoid arthritis who inadequately responded or were intolerant to one or more DMARDs (disease-modifying antirheumatic drugs).

In June 2017, the European Commission also granted marketing authorization to Kevzara in combination with methotrexate for treatment of the same indication.

Clinical trial outcomes

Regeneron Pharmaceuticals conducted the MOBILITY trial, which evaluated the safety and efficacy of Kevzara in combination with methotrexate compared to placebo and methotrexate combination therapy. In the MOBILITY trial, Kevzara and methotrexate combination therapy achieved the parameters of the primary endpoint (ACR20: 20% improvement in American College of Rheumatology Criteria) of 66% and 58% for patients on Kevzara 200mg and Kevzara 150mg compared to 33% for placebo-treated patients.

Regeneron Pharmaceuticals conducted the TARGET trial, which evaluated the safety and efficacy of Kevzara and DMARDs combination therapy compared to placebo and DMARDs. In the TARGET trial, Kevzara and DMARD combination therapy achieved the parameters of the primary endpoint of ACR20 with 61% and 56% of patients on Kevzara 200mg and Kevzara 150mg compared to 34% for patients on the placebo.

Regeneron Pharmaceuticals conducted the phase three MONARCH trial, which evaluated the safety and efficacy of Kevzara 200mg compared to AbbVie’s (ABBV) Humira. In the MONARCH trial, patients on Kevzara achieved the primary endpoint criteria for changes in baseline in DAS28-ESR (Disease Activity Score with 28 joint count and erythrocyte sedimentation rate).

The iShares Nasdaq Biotechnology ETF (IBB) invests ~1.9% and 2.7% of its total portfolio holdings in rheumatology drug innovators Amgen (AMGN) and Regeneron, respectively. The growth in sales of Regeneron’s Kevzara and Amgen’s Enbrel could boost IBB. In 3Q17, Enbrel and Kevzara generated revenues of $1.4 billion and $3 million, respectively.

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