Sanofi announces licensing of Kevzara® in treatment of RA

Amy Schofield 27 June 2017

Sanofi and its specialty care global business unit, Sanofi Genzyme, have announced 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).

Sarilumab may be used as monotherapy in case of intolerance to MTX or when treatment with methotrexate is inappropriate.

The EC marketing authorisation is based upon receipt of a positive opinion by the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

The committee evaluated results from seven Phase 3 trials in the global SARIL-RA clinical development programme of more than 3300 adults with moderately to severely active RA who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs.

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.

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, all of which has a negative impact on daily life.  

Professor Peter Taylor, Consultant Rheumatologist, Oxford University Hospitals, said: “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. New treatment options are an important part of the solution to this problem.” 

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