A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis
Phase of Trial: Phase III
Latest Information Update: 01 Feb 2018
At a glance
- Drugs Sarilumab (Primary) ; Bucillamine; Leflunomide; Mizoribine; Tacrolimus
- Indications Rheumatoid arthritis
- Focus Adverse reactions; Registrational
- Acronyms SARIL-RA-HARUKA
- Sponsors Sanofi
- 10 Jun 2017 Biomarkers information updated
- 22 May 2017 According to a Sanofi media release, based on the data from approximately 2,900 adults the US FDA has approved Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more DMARDs, such as methotrexate (MTX).
- 28 Apr 2017 According to a Regeneron Pharmaceuticals media release, the US FDA has accepted the resubmission of the Biologics License Application for sarilumab (Kevzara) as a Class I response with a two month review timeline. Per the Prescription Drug User Fee Act (PDUFA), the new target action date is May 22, 2017.