Scenesse - afamelanotide

What is Scenesse - afamelanotide and what is it used for?

Scenesse is a plant used to treat patients with erythropoietic protoporphyria (EPP), a rare disease that causes light intolerance. In patients with EPP, exposure to light can cause symptoms such as pain and swelling of the skin, which prevent them from being outdoors or in places with intense light. Scenesse is indicated for the prevention or reduction of these symptoms, to allow patients to live a more normal life. Because the number of patients with EPP is low, the disease is considered "rare" and Scenesse was qualified as an "orphan medicine" (a medicine used in rare diseases) on 8 May 2008. Scenesse contains the active substance afamelanotide .

How is Scenesse used - afamelanotide?

Scenesse should only be prescribed by specialist physicians, in centers approved for the treatment of EPP, and should only be used by appropriately trained medical experts. A Scenesse implant is inserted into the patient's subcutaneous tissue every 2 months before and during periods of increased exposure to sunlight, for example from spring to autumn. The number of implants inserted each year depends on how much protection from sunlight is needed. Yes

How does Scenesse - afamelanotide work?

The active ingredient of Scenesse, afamelanotide, is similar to a hormone in the body, called the alpha-melanocyte stimulating hormone, which stimulates the production of a brown-black pigment in the skin. This pigment, known as eumelanin, is produced during exposure to sunlight to block the penetration of light into cells. High levels of a substance called protoporphyrin IX are found in the body of EPP patients. Protoporphyrin IX is phototoxic and, if exposed to light, causes the pain reactions observed in patients suffering from this condition. By stimulating the production of eumelanin in the skin, Scenesse reduces the penetration of light through the skin, helping to prevent painful reactions.

What benefit has Scenesse - afamelanotide shown during the studies?

During a study Scenesse has been shown to induce an increase in time that patients can spend in places exposed to sunlight. In the study, in which 93 patients with EPP participated, patients were treated with Scenesse or placebo (a dummy treatment) for a period of more than six months. From the daily records of exposure to sunlight between 10.00 and 18.00 it was found that patients treated with Scenesse spent on average 116 hours under direct sunlight without experiencing pain in the six months of the study compared to 61 hours of patients treated with placebo.

What is the risk associated with Scenesse - afamelanotide?

The most common side effects observed in the studies with Scenesse were nausea, headache and reactions at the implant site (including alteration of skin color, pain and redness). These reactions involved approximately 1 in 5 patients and generally showed a mild degree of severity. Scenesse should not be given to patients with impaired hepatic or renal function. For the full list of all side effects and restrictions with Scenesse, see the package leaflet.

Why has Scenesse - afamelanotide been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Scenesse's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that Scenesse led to an increase in the duration of exposure of patients to direct sunlight without the appearance of pain. Although this increase in the duration of exposure to sunlight is modest, in deciding to recommend authorization for Scenesse in the EU the committee took into account potential improvements in quality of life, unmet medical demand in patients with EPP and mild side effects observed during brief therapy with the medicine. The committee also individually consulted patients and experts on their experience with Scenesse. Scenesse was authorized in "exceptional circumstances" because it was not possible to obtain complete information on Scenesse due to the rarity of the disease. Every year the European Medicines Agency will review the new information available and this summary will be updated accordingly. What measures are being taken to ensure the safe and effective use of Scenesse - afamelanotide?

What information is still awaited for Scenesse - afamelanotide?

As Scenesse has been authorized in exceptional circumstances, the company that markets Scenesse will provide long-term data on the benefits and safety of the medicine, deriving them from an EU register of patients taking the medicine.

What measures are being taken to ensure the safe and effective use of Scenesse - afamelanotide?

A risk management plan has been developed to ensure that Scenesse 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 Scenesse, including the appropriate precautions to be followed by healthcare professionals and patients. Furthermore, the company that markets Scenesse will distribute information material to doctors and instruct them in the use of the medicine. In addition, doctors will be given information on the EU register. Further information is available in the summary of the risk management plan.

More information on Scenesse - afamelanotide

On 22 December 2014, the European Commission issued a marketing authorization for Scenesse, valid throughout the European Union. For more information on Scenesse therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The summary of the opinion of the Committee for Orphan Medicinal Products related to Scenesse is available on the Agency's website: ema.Europa.eu/Find medicine / Human medicines / Rare disease designation. Last update of this summary: 12-2014.