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Sanofi Announces Licensing of Kevzara® (sarilumab) to Treat Adult Patients with Moderately to Severely Active Rheumatoid Arthritis (RA) in the European Union

Marketing authorisation for sarilumab offers a new treatment option for people in the UK living with the debilitating effects of RA

 

Guildford, UK – 27 June, 2017 – Sanofi and its specialty care global business unit, Sanofi Genzyme, announced today that the European Commission (EC) has granted marketing authorisation for Kevzara® (sarilumab) in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis (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 may be used as monotherapy in case of intolerance to MTX or when treatment with methotrexate is inappropriate.1

“Despite of a wide range of treatment options,many people with RA do not respond adequately to existing treatments or experience loss of response to therapy over time. Symptoms can be debilitating and greatly impact the ability to perform daily activities,” said Professor Peter Taylor, Consultant Rheumatologist, Oxford University Hospitals. “New treatment options are an important part of the solution to this problem.”

“RA is a chronic and debilitating lifelong disease and despite existing treatment options, there are still patients in need of an effective alternative,” added Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme. “Sarilumab presents an additional option for those people and is a welcome addition to the physician’s prescribing toolkit.”

RA is one of the most common rheumatic conditions, affecting more than 400,000 people living in the UK and approximately 2.9 million people in Europe.2,3,4 People with RA can suffer from severe pain, swelling, stiffness, or fatigue as the immune system attacks the tissues of the joints, causing inflammation and destroying bone and cartilage.5 The impact these symptoms and complications have on daily life is often underestimated.

The EC marketing authorisation is based upon receipt of a positive opinion by European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).6 The committee evaluated results from seven Phase 3 trials in the global SARIL-RA clinical development programme of 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.6-13

Sarilumab was developed jointly by Sanofi and Regeneron. Full summary of product characteristics can be accessed at http://www.medicines.org.uk/emc/.

About Rheumatoid Arthritis (RA)

RA is a chronic systemic autoimmune disease that can affect people of any age but is most common in people aged between 30-50 years14 with 75% of patients diagnosed while of working age.15 Up to two in five people with inadequately treated rheumatoid arthritis will have stopped working within five years of being diagnosed.4 RA occurs more often in women than in men (75% vs 25%) and can be seriously debilitating, preventing people from completing everyday activities like washing their hair and cooking a meal.16 People with RA are at an increased risk of cardiovascular disease, infections and certain cancers.17 In addition, as many as 40% of people with RA may experience significant symptoms of depression.18

About Kevzara® (sarilumab)

Sarilumab is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to block pro-inflammatory IL-6 mediated signalling.19 IL-6 is a protein in the body that, in excess and over time, can contribute to both the pathological inflammation and joint destruction that are associated with RA.19

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: June 2017 - Job bag number: SAGB.SARI.17.06.0691

Updated: June 27, 2017

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