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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/599079/2013

EMEA/H/C/000900

EPAR summary for the public

Intelence

etravirine

This document is a summary of the European Public Assessment Report (EPAR) for Intelence. 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 Intelence.

What is Intelence?

Intelence is a medicine that contains the active substance etravirine. It is available as tablets (25,

100 and 200 mg).

What is Intelence used for?

Intelence is used to treat adults and children from six years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Intelence is only used in patients who have been treated for their HIV infection before. Intelence must be used together with other anti-HIV medicines that include a 'boosted protease inhibitor'.

The medicine can only be obtained with a prescription.

How is Intelence used?

Treatment with Intelence should be started by a doctor who has experience in the treatment of HIV infection.

In adults, the recommended dose of Intelence is 200 mg (as two 100 mg tablets or one 200 mg tablet) twice a day after a meal. In children, the dose depends on body weight and ranges from 100 mg twice a day to 200 mg twice a day. For patients who are unable to swallow the tablets, Intelence tablets can

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be dispersed by stirring them in a glass of water to form a milky solution. This solution has to be drunk immediately.

How does Intelence work?

The active substance in Intelence, etravirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses. By blocking this enzyme, Intelence, taken in combination with other anti-HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level. Intelence does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Intelence been studied?

Intelence has been studied in two main studies in adults, involving a total of 1,203 HIV-infected adults who had been taking anti-HIV therapy that was not working any longer and who had few or no treatment options remaining. Both studies compared Intelence with placebo (a dummy treatment), when they were taken with boosted darunavir (a protease inhibitor) and at least two other anti-HIV medicines that were chosen for each patient as they had the best chances of reducing the levels of HIV in the blood. Intelence has also been studied in one main study involving 101 children aged between six and 17 years old who were infected with HIV and were already taking anti-HIV medicines. In this study, Intelence was not compared with another treatment and the children also took at least two other anti-HIV medicines. The main measure of effectiveness in all the studies was the number of patients with a level of HIV in the blood (viral load) that was below 50 copies/ml after 24 weeks of treatment.

What benefit has Intelence shown during the studies?

Intelence was more effective than placebo at reducing viral load in adults. Looking at the two studies in adults together, the average viral load was 70,000 copies/ml at the start of the studies. After 24 weeks, 59% of the patients taking Intelence (353 out of 599) had a viral load below 50 copies/ml, compared with 41% of those taking placebo (248 out of 604). These findings were maintained at 48 weeks. In children, 51.5% (52 out of 101) of the study participants had a viral load below 50 copies/ml after 24 weeks of taking Intelence, and this was slightly increased after 48 weeks.

What is the risk associated with Intelence?

The most common side effect with Intelence (seen in more than 1 patient in 10) is rash. For the full list of all side effects reported with Intelence, see the package leaflet.

Why has Intelence been approved?

The CHMP decided that Intelence's benefits are greater than its risks and recommended that it be given marketing authorisation.

Intelence was originally given 'conditional approval' because there was more evidence to come about the medicine, in particular regarding its use in combination with protease inhibitors other than darunavir. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.

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

A risk management plan has been developed to ensure that Intelence 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 Intelence, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Intelence

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Intelence on 28 August 2008. This was switched to a full marketing authorisation on 20 November 2013.

The full EPAR for Intelence 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 Intelence, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 10-2013.

Intelence

EMA/599079/2013

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