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Sanofi Receives CHMP Positive Opinion for Kevzara® (sarilumab) to Treat Adult Patients with Moderately to Severely Active Rheumatoid Arthritis

April 24, 2017

First regulatory milestone for sarilumab achieved in the UK, where 700,000 people suffer with rheumatoid arthritis

 

Guildford, UK – 24 April, 2017 - Sanofi and its specialty care global business unit, Sanofi Genzyme, today announced that the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of Kevzara® (sarilumab), recommending its approval for use in adult patients with moderately to severely active rheumatoid arthritis.

“The CHMP positive recommendation for sarilumab marks an important milestone in our mission to bring a new treatment option to physicians and people with rheumatoid arthritis across the United Kingdom”, said Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme. Despite several therapeutic advancements for rheumatoid arthritis (RA) over recent years, an unmet need remains with RA, still impacting the lives of approximately 700,000 people in the UK.”

The CHMP recommended the use of sarilumab in combination with methotrexate (MTX) for the treatment of moderately to severely active RA in adult patients who have responded inadequately to, or who are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs).1 Sarilumab can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.1

The CHMP opinion is 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 who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs.2,3,4,5,6,7,8 The European Commission (EC) is expected to make a final decision on the Marketing Authorization Application (MAA) for sarilumab in the European Union in the coming months.

In the United Kingdom, approximately 700,000 people suffer from rheumatoid arthritis, which targets joint tissues causing inflammation, pain and restricted movement, often resulting in damage and disability.9 People with rheumatoid arthritis are also at increased risk of developing cardiovascular conditions, anaemia, lung complications and nerve compression injuries. With rheumatoid arthritis most often striking people between 40 and 60 years old,10 their ability to work can be significantly affected and four in ten with inadequately treated rheumatoid arthritis will have stopped working within five years of disease onset.9 Therapeutic options to prevent disease progression and damage are therefore important to improve all aspects of life for people with rheumatoid arthritis.

About Sarilumab

Kevzara® (sarilumab) is 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 RA who had an inadequate response or intolerance to one or more biologic or non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

IL-6 is the most abundant cytokine in the serum and synovial fluid of patients with RA and levels correlate with both disease activity and joint destruction.11

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organised into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

References

Date of preparation: April 2017 - Job bag number: SAGB.SARI.17.04.0489

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