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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/470140/2012

EMEA/H/C/000179

EPAR summary for the public

Zyclara

imiquimod

This is a summary of the European public assessment report (EPAR) for Zyclara. 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 Zyclara.

What is Zyclara?

Zyclara is a cream containing the active substance imiquimod. It is available as 250 mg sachets, each containing 9.375 mg imiquimod (3.75%).

Zyclara is a 'hybrid medicine'. This means that it is similar to a 'reference medicine' containing the same active substance, but Zyclara is available in a different strength. The reference medicine for Zyclara is Aldara, which contains imiquimod at 5% strength.

What is Zyclara used for?

Zyclara is used to treat actinic keratosis on the face and balding parts of the scalp. Actinic keratosis is a precancerous, abnormal skin growth that develops after too much exposure to sunlight. Zyclara is used to treat adults whose immune system (the body's natural defences) is working normally when other skin treatments for actinic keratosis cannot be used or are less appropriate.

The medicine can only be obtained with a prescription.

How is Zyclara used?

Zyclara cream is applied in a thin layer to the affected areas of the face or balding scalp once a day before bedtime. The cream should remain on the skin overnight (for about eight hours) before being washed off. Treatment with daily application should continue for two weeks. This is followed by a two-

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week break without treatment and then a further two weeks of treatment. For further information, see the package leaflet.

The patient's response to treatment should be evaluated eight weeks after the end of treatment.

How does Zyclara work?

The active substance in Zyclara cream, imiquimod, is an immune response modifier. This means that it uses the immune system to bring about its effect. When imiquimod is applied to the skin, it acts locally on the immune system to trigger the release of cytokines, including interferon. These substances help to kill abnormal cells in the skin that can lead to keratosis.

How has Zyclara been studied?

Zyclara has been investigated in two main studies involving 479 patients with actinic keratosis on the face and scalp. Two doses of Zyclara (2.5% and 3.75%) were compared with placebo (a dummy treatment) in these studies and the main measure of effectiveness was the number of patients whose skin was completely cleared of the actinic keratosis after treatment.

What benefit has Zyclara shown during the studies?

Zyclara was shown to be effective in clearing actinic keratosis from the skin. Around 36% of patients treated with Zyclara 3.75% cream in the two studies had complete clearance compared with around 6% of patients treated with placebo. Zyclara at a lower strength (2.5%) had a lower clearance rate than the 3.75% strength.

What is the risk associated with Zyclara?

Most patients using Zyclara experience local skin side effects (most commonly redness, scab formation, dryness and shedding of the skin). About 11% of patients in studies with Zyclara required treatment to be interrupted due to local side effects. Some other side effects, including headache and tiredness, were also reported. For the full list of all side effects reported with Zyclara, see the package leaflet.

Zyclara must not be used in people who are hypersensitive (allergic) to imiquimod or any of the other ingredients.

Why has Zyclara been approved?

The CHMP concluded that Zyclara 3.75% cream had been shown to be effective at clearing actinic keratosis from the skin and that its use did not raise significant safety concerns. Treatment with Zyclara has the advantage of being easier to adhere to than Aldara treatment because it has a simpler dosing regimen. In addition, its lower strength allows it to be used across larger areas of the skin and thereby treat more of the affected skin.

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

Other information about Zyclara

The European Commission granted a marketing authorisation valid throughout the European Union for Zyclara on 23 August 2012.

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

The full EPAR for the reference medicine can also be found on the Agency's website.

This summary was last updated in 08-2012.

Zyclara

EMA/470140/2012

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