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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/632414/2016

EMEA/H/C/002204

EPAR summary for the public

Ameluz

5-aminolaevulinic acid

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

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

What is Ameluz and what is it used for?

Ameluz is used in adults to treat mild to moderate actinic keratosis (abnormal skin growths that develop after too much exposure to sunlight, which can lead to skin cancer) on the face and scalp. It may also be used to treat an area of sun-induced skin damage with multiple actinic keratosis growths (field cancerisation). The medicine contains the active substance 5-aminolaevulinic acid.

How is Ameluz used?

Ameluz is available as a gel (78 mg/g). It can only be obtained with a prescription and should only be given under the supervision of a healthcare professional experienced in using photodynamic therapy. This method of treatment involves applying a brief illumination from a strong red light source designed for this purpose. Red light activates the medicine.

Ameluz is applied to the skin growths and, three hours later, a red light source is shone onto them. Single or multiple growths may be treated in one session. The state of the growths should be monitored three months later, and any remaining growths should be re-treated.

How does Ameluz work?

Ameluz is used in photodynamic therapy, a technique that involves shining a light on an area of skin which has been made sensitive to the light. When Ameluz is applied to the abnormal skin growths in actinic keratosis, the active substance in Ameluz, 5-aminolaevulinic acid, is absorbed into their cells

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where it acts as a photosensitising agent (a substance that changes when exposed to light of a certain wavelength). When the affected skin is illuminated with the light, the photosensitising agent is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen. This kills the cells by reacting with and destroying their components, such as proteins and DNA.

What benefits of Ameluzhave been shown in studies?

Ameluz was more effective than placebo or a comparator medicine when used in photodynamic therapy to treat actinic keratosis. The effects of Ameluz in were examined in three main studies in patients with actinic keratosis. The main measure of effectiveness in these studies was the total number of patients whose actinic keratoses had all cleared up three months after the last treatment.

In the first main study involving 571 patients, Ameluz was compared with placebo and Metvix, a product containing methylaminolaevulinate, used for one or two treatment sessions. Actinic keratosis cleared up in 78% (194 out of 248) of patients treated with Ameluz, compared with 64% (158 out of 246) of patients treated with Metvix and 17% (13 out of 76) of patients treated with placebo.

In the second main study involving 122 patients, Ameluz was compared with placebo used for one or two treatment sessionsActinic keratosis cleared in 66% (53 out of 80) of patients treated with Ameluz, compared with 13% (5 out of 40) of patients treated with placebo.

In the third study, involving 87 patients with field cancerisation (an area of sun damage with several actinic keratosis growths), Ameluz was compared with placebo used for one or two treatment sessions. The condition cleared up in 91% of patients given Ameluz (50 out of 55), compared with 22% (7 of 32) given placebo.

What are the risks associated with Ameluz?

The most common side effects with Ameluz (seen in more than 1 patient in 10) are reactions at the site of application, including irritation, erythema (reddening of the skin), pain, pruritus (itching), oedema (swelling), exfoliation (skin peeling), scab formation and induration (hardening of the skin). For the full list of all side effects reported with Ameluz, see the package leaflet.

Ameluz must not be given to people who are hypersensitive (allergic) to 5-aminolaevulinic acid, porphyrins, soybeans or peanuts, or any of the other ingredients. It must not be used in people who have porphyria (an inability to break down chemicals called porphyrins) or people who have certain skin diseases of different origins caused by exposure to light. For the full list of restrictions, see the package leaflet.

Why is Ameluz approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of treatment with Ameluz were greater than the few and mostly mild side effects, and that Ameluz was more effective and somewhat safer than the standard alternative. The Committee therefore concluded that the benefits of Ameluz are greater than its risks and recommended that it be granted marketing authorisation.

Other information about Ameluz

The European Commission granted a marketing authorisation valid throughout the European Union for Ameluz on 14 December 2011.

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

This summary was last updated in 09-2016.

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Ameluz

EMA/632414/2016