EMA acceptance for review of marketing authorisation application for sarilumab

Sanofi and Regeneron Pharmaceuticals 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).¹

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 3300 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.^2-8

A biologics license application (BLA) for sarilumab was accepted for review by the US Food and Drug Administration (FDA) in the first quarter of 2016. Per the Prescription Drug User Fee Act (PDUFA), the target action date is 30 October 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.

References

1. Huizinga TWJ, Fleischmann RM, Jasson M, et al. “Sarilumab, a fully human monoclonal antibody against IL-6Rα in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomized SARIL-RA-MOBILITY Part A trial.” Annals of Rheumatic Diseases 2014; 73(9): 1626-1634.
2. Sanofi. Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015]. Available from: https://clinicaltrials.gov/ct2/show/NCT02332590 NLM Identifier: NCT02332590.
3. Sanofi. Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients (RA-MOBILITY). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015]. Available from: https://clinicaltrials.gov/show/NCT01061736 NLM Identifier: NCT01061736.
4. Sanofi. To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015]. Available from: NLM Identifier: https://clinicaltrials.gov/ct2/show/NCT01709578 NLM Identifier: NCT01709578.
5. Sanofi. To Evaluate Sarilumab – SAR153191 (REGN88) – Auto-injector Device In Patients With Rheumatoid Arthritis (SARIL-RA-EASY). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015]. Available from: https://clinicaltrials.gov/ct2/show/NCT02057250 NLM Identifier: NCT02057250.
6. Sanofi. To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015]. Available from: https://clinicaltrials.gov/show/NCT01768572 NLM Identifier: NCT01768572.
7. Sanofi. Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (RA-EXTEND). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015]. Available from: https://clinicaltrials.gov/show/NCT01146652 NLM Identifier: NCT01146652.
8. Sanofi. To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA) (SARIL-RA-ONE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015]. Available from: https://clinicaltrials.gov/ct2/show/NCT02121210 NLM Identifier: NCT02121210.