Vaniqa

eflornithine

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Vaniqa?

Vaniqa is a white cream that contains 11.5% of the active substance eflornithine.

What is Vaniqa used for?

Vaniqa is used for the treatment of facial hirsutism in women. Facial hirsutism is excessive growth on the face of coarse hair, often in a male pattern.

The medicine can only be obtained with a prescription.

How is Vaniqa used?

Vaniqa is applied in a thin layer to clean and dry affected areas twice daily (at least eight hours apart) and rubbed in. A benefit may be noticed within eight weeks of starting treatment. Continued treatment may give further improvement and is necessary to maintain beneficial effects. Vaniqa should be stopped if no beneficial effects are noticed within four months of starting treatment. Women using Vaniqa may still need to use other means to remove hair (plucking, shaving).

How does Vaniqa work?

Vaniqa contains the active substance eflornithine. Eflornithine blocks the action of an enzyme, ornithine decarboxylase. This enzyme is found in the bulb of the hair follicle where it controls hair production. When this enzyme is blocked, the growth of hair is slowed down.

How has Vaniqa been studied?

The effectiveness of Vaniqa has been studied in two clinical trials including 596 women treated for up to 24 weeks with Vaniqa, or with a placebo (a dummy treatment, in this case the cream without any active substance). The effectiveness of the treatment was assessed by the doctor at the end of the study who graded the hirsutism as: ‘clear/almost clear’, ‘marked improvement’, ‘improved’ or ‘no improvement/worse’, 48 hours after women had shaved the treated areas of the face and under the chin.

What benefit has Vaniqa shown during the studies?

Improvement was seen as early as 8 weeks after the start of treatment. Significant improvement for Vaniqa versus placebo was seen in both studies. When the results were combined, a successful outcome (graded as ‘clear/almost clear’ or ‘marked improvement’) was seen in 35% of women treated with Vaniqa, against 9% of those treated with placebo.

What is the risk associated with Vaniqa?

The most common side effect (seen in more than 1 patient in 10) is acne. Other common side effects are pseudofolliculitis barbae (ingrown hairs), alopecia (hair loss), stinging skin, burning skin, dry skin, pruritus (itching), erythema (redness), tingling skin, irritated skin, rash, and folliculitis (infected hair follicles). For the full list of all the side effects reported with Vaniqa, please see the Package Leaflet.

Vaniqa should not be used in people who may be hypersensitive (allergic) to eflornithine or to any of the other ingredients.

Why has Vaniqa been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that Vaniqa’s benefits are greater than its risks for the treatment of facial hirsutism in women. They recommended that Vaniqa be given marketing authorisation (made available to doctors).

Other information about Vaniqa

The European Commission granted a marketing authorisation valid throughout the European Union, for Vaniqa in on 20 March 2001. The marketing authorisation holder is Laboratorios Almirall, S.A.

This EPAR was last updated on 08/10/2010 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

30/09/2010  Vaniqa -EMEA/H/C/000325 -IA/0033

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Other dermatological preparations

Therapeutic indication

Treatment of facial hirsutism in women.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents