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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/289865/2012

EMEA/H/C/002015

EPAR summary for the public

Benlysta

belimumab

This is a summary of the European public assessment report (EPAR) for Benlysta. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Benlysta.

What is Benlysta?

Benlysta is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance belimumab.

What is Benlysta used for?

Benlysta is used as an add-on treatment for systemic lupus erythematosus (SLE) in adults with a positive autoantibody test whose disease is still highly active despite standard treatment.

The medicine can only be obtained with a prescription.

How is Benlysta used?

Benlysta treatment should only be started and supervised by a doctor who has experience in the diagnosis and treatment of SLE.

Benlysta is given as an infusion (drip) into a vein over one hour. The recommended dose is 10 mg per kilogram body weight. The first three doses are given at two-week intervals. After this, Benlysta is given once every four weeks.

The doctor may interrupt or stop treatment if the patient develops reactions linked to the infusion (such as rash, itchiness and difficulty breathing) or hypersensitivity (allergic) reactions which may be severe and life-threatening and can develop several hours after Benlysta is given. Patients should therefore be observed for several hours after at least the first two infusions and Benlysta should

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always be given to patients in a place where these reactions can be managed immediately if they occur.

How does Benlysta work?

SLE is a disease in which the immune system (the body's natural defences) attacks cells and tissues of the patient, causing inflammation and organ damage. SLE can affect almost any organ in the body, and is thought to involve a type of white blood cell called B lymphocytes. Usually, B lymphocytes produce antibodies which help to fight infections. In SLE, some of these antibodies attack the body's own cells and organs instead (autoantibodies).

The active substance in Benlysta, belimumab, is a monoclonal antibody. A monoclonal antibody is an antibody that has been designed to recognise and attach to a specific structure (called an antigen). Belimumab has been designed to attach to and block a protein called BLyS which helps B lymphocytes to live longer. By blocking the action of BLyS, belimumab reduces the life span of B lymphocytes, thereby reducing the inflammation and organ damage that occur in SLE.

How has Benlysta been studied?

Benlysta (given at doses of 1 and 10 mg per kg bodyweight) has been compared with placebo (a dummy treatment) in two main studies involving 1,693 adult patients with active SLE. The patients continued to receive their standard treatments for SLE during the studies. In both studies, the main measure of effectiveness was the number of patients whose disease activity decreased to a certain level after 12 months.

What benefit has Benlysta shown during the studies?

Benlysta was shown to be more effective than placebo in reducing disease activity when used as an add-on treatment for SLE. In the first study, in 43% of patients Benlysta 10 mg/kg was effective, compared with 34% of patients who were given placebo. In the second study, in 58% of patients Benlysta 10 mg/kg was effective compared with 44% of patients who were given placebo. In both studies, the 10 mg/kg dose of Benlysta was more effective than the 1 mg/kg dose.

What is the risk associated with Benlysta?

The most common side effects with Benlysta (seen in more than 1 patient in 10) are bacterial infections, such as bronchitis (inflammation of the airways in the lungs) and cystitis (inflammation in the bladder), diarrhoea and nausea (feeling sick). For the full list of all side effects and restrictions with Benlysta, see the package leaflet.

Why has Benlysta been approved?

The CHMP considered that Benlysta, used as an add-on treatment, reduced disease activity in SLE without serious risk to the patient. The medicine may cause infusion and hypersensitivity reactions as well as infections, but is generally well tolerated. The CHMP also noted the lack of effective alternative treatments for patients who have already tried standard treatments. The Committee decided that Benlysta's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Benlysta?

The company will provide further information on the safety of Benlysta from a study and from a register of patients being followed up long-term.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Benlysta have also been included in the summary of product characteristics and the package leaflet.

Other information about Benlysta

The European Commission granted a marketing authorisation valid throughout the European Union for Benlysta on 13 July 2011.

The full EPAR for Benlysta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Benlysta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2016.

Benlysta

EMA/522853/2016

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