- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Sanofi and Regeneron announce EMA acceptance for review of Marketing Authorisation Application for sarilumab
1 August 2016 • Author: Sanofi / Regeneron Pharmaceuticals, Inc.
Sanofi and Regeneron Pharmaceuticals, Inc. have announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for sarilumab, an investigational human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
The MAA for sarilumab is primarily based on results from seven Phase 3 trials in the global SARIL-RA clinical development programme, including SARIL-RA-MOBILITY, SARIL-RA-TARGET and SARIL-RA-MONARCH. These studies incorporate data from more than 3,300 adults with moderately to severely active RA the majority of who were inadequate responders to previous treatment regimens such as disease-modifying anti-rheumatic drugs (DMARDs) or anti-tumour necrosis factor alpha (anti-TNFα).
The goal of the clinical development programme has been to evaluate the safety and efficacy of sarilumab, either as monotherapy or in combination with conventional DMARDs, including methotrexate (MTX), in reducing the signs and symptoms, improving physical function and inhibiting the radiographic progression of RA. The extension part of the SARIL-RA-MONARCH trial and a long term safety trial called SARIL-RA-EXTEND are ongoing.
A biologics license application (BLA) for sarilumab was accepted for review by the U.S. Food and Drug Administration (FDA) in the first quarter of 2016. Per the Prescription Drug User Fee Act (PDUFA), the target action date is Oct. 30, 2016.
The safety and efficacy of sarilumab have not been fully evaluated by any regulatory authority. If authorised, sarilumab would be commercialised by Regeneron and Sanofi Genzyme, the specialty care global business of Sanofi.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics