EMA/CHMP/871646/2011

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
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
Ameluz.

What is Ameluz?

Ameluz is a medicine that contains the active substance 5-aminolaevulinic acid. It is available as a gel
(78 mg/g).

What is Ameluz used for?

Ameluz is used 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.

The medicine can only be obtained with a prescription.

How is Ameluz used?

Ameluz 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 photosensitising agent in the Ameluz
gel.

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.

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© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
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
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.

How has Ameluz been studied?

The effects of Ameluz were first tested in experimental models before being studied in humans.

The effects of Ameluz in photodynamic therapy were examined in two main studies in patients with
actinic keratosis. 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. In
the second main study involving 122 patients, Ameluz was compared with placebo used for one or two
treatment sessions. The main measure of effectiveness in both studies was the total number of
patients with all actinic keratoses had cleared up three months after the last treatment.

What benefit has Ameluz shown during the studies?

Ameluz was more effective than placebo and the comparator medicine when used in photodynamic
therapy to treat actinic keratosis. In the first study, the actinic keratosis had cleared up three moths
after treatment for 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 study, the actinic keratosis had cleared up three months after treatment for 66% (53 out of
80) of patients treated with Ameluz, compared with 13% (5 out of 40) of patients treated with placebo.

What is the risk 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 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 has Ameluz been approved?

The 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.

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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 11-2011.

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