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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/337860/2014

EMEA/H/C/002782

EPAR summary for the public

Entyvio

vedolizumab

This is a summary of the European public assessment report (EPAR) for Entyvio. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Entyvio.

For practical information about using Entyvio, patients should read the package leaflet or contact their doctor or pharmacist.

What is Entyvio and what is it used for?

Entyvio is a medicine that contains the active substance vedolizumab. It is used to treat adult patients with ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut) or Crohn's disease (a disease causing inflammation of the digestive tract). Vedolizumab is used to treat moderate to severe active disease when conventional therapy or medicines called TNF-alfa antagonists are ineffective, no longer effective, or cannot be tolerated by the patient.

How is Entyvio used?

Entyvio is available as a powder to be made up into a solution for infusion (drip) into a vein. It can only be obtained with a prescription and treatment should be started and supervised by a specialist who has experience in the diagnosis and treatment of ulcerative colitis or Crohn's disease.

The recommended dose is 300 mg given at weeks zero, two and six, and then every eight weeks after that in patients who respond.

Entyvio is given as an infusion that lasts 30 minutes. All patients are monitored for any reactions during the infusion and for at least one to two hours after the end of the infusion. For more information, see the package leaflet.

Patients who receive Entyvio must be given a special alert card that summarises the safety information about the medicine.

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How does Entyvio work?

The active substance in Entyvio, vedolizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Vedolizumab has been designed to attach to 'alfa-4-beta-7 integrin', a protein mostly found on the surface of certain white blood cells in the gut. In ulcerative colitis and Crohn's disease these cells are involved in causing inflammation in the gut. By blocking alfa-4-beta-7 integrin, vedolizumab reduces the inflammation in the gut and the symptoms of these diseases.

Entyvio is produced by a method known as 'recombinant DNA technology'; it is made by cells into which a gene (DNA) has been introduced that makes them able to produce vedolizumab.

What benefits of Entyvio have been shown in studies?

In ulcerative colitis, Entyvio has been investigated in a main study in patients with moderate to severe active disease in whom conventional therapy or TNF-alfa antagonists were ineffective or could not be tolerated. Patients received either Entyvio or placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients whose symptoms improved after 6 weeks of treatment. Entyvio was shown to be more effective than placebo: 47% (106 out of 225) of patients who received Entyvio showed an improvement in symptoms, compared with 26% (38 out of 149) of patients who received placebo. In addition, the study also showed that Entyvio maintained the effect up to 52 weeks more effectively than placebo.

Entyvio was also shown to be more effective than placebo at improving symptoms of Crohn's disease.

In one main study in adult patients with moderate to severe active Crohn's disease in whom conventional therapy or TNF-alfa antagonists were ineffective or could not be tolerated, 15% (32 out of 220) of patients receiving Entyvio showed improved symptoms after 6 weeks of treatment, compared with 7% (10 out of 148) of patients on placebo. Similarly, in this study the maintenance of the effect up to 52 weeks with Entyvio was more effective than with placebo.

What are the risks associated with Entyvio?

The most common side effects with Entyvio (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat such as a cold), headache and arthralgia (joint pain). For the full list of all side effects reported with Entyvio, see the package leaflet.

Entyvio must not be used in people with active serious infections such as tuberculosis, sepsis (infection in the blood), listeriosis (infection with bacteria called Listeria) or opportunistic infections (those seen in patients with a weakened immune system) such as progressive multifocal leukoencephalopathy (PML, a rare brain infection that usually leads to severe disability or death). For the full list of restrictions, see the package leaflet.

Why is Entyvio approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Entyvio's benefits are greater than its risks and recommended that it be approved for use in the EU. In ulcerative colitis, the Committee considered that the benefit of Entyvio has been clearly demonstrated, which is relevant for patients who do not respond to TNF-alfa therapy. Furthermore, the risks are considered manageable, despite the lack of long-term safety data, if recommendations in place are followed.

In Crohn's disease, the CHMP considered that although the time required for improvement of symptoms may be longer and the size of the effect limited when compared with anti-TNF-alfa therapy, Entyvio still offers a benefit for patients because of its different mechanism of action and safety profile.

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

A risk management plan has been developed to ensure that Entyvio is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Entyvio, including the appropriate precautions to be followed by healthcare professionals and patients.

The company will also provide educational material to all healthcare professionals expected to prescribe Entyvio to remind them of the need to monitor patients for signs of neurological disease or PML, in particular those treated with certain biological medicines which may potentially cause PML.

Further information can be found in the summary of the risk management plan.

Other information about Entyvio

The European Commission granted a marketing authorisation valid throughout the European Union for Entyvio on 22 May 2014.

The full EPAR and risk management plan summary for Entyvio 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 Entyvio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2014.

Entyvio

EMA/337860/2014

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