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Zyclara receives positive opinion from the Committee for Human Medicinal Products in the European Union

Monday, 25 June 2012
The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding marketing authorization of Zyclara (treatment of actinic keratoses on large skin areas). The European Commission generally follows the recommendations of the CHMP (EMA) and announces its final decision within three months after the recommendation. Following an approval, the marketing authorization is valid across the European Union.
"I’m pleased that the CHMP has adopted a positive opinion for Zyclara, which will further strengthen Meda’s product portfolio in dermatology. Our launch pipeline looks very promising", said Anders Lönner, CEO of Meda AB.
About actinic keratosis and Zyclara
Actinic keratosis (AK), early skin carcinoma in situ is an under-diagnosed and under-treated disease and the number of affected patients is increasing. There is a close regional coexistence of invisible (subclinical AK lesions) as well as clinical visible AK lesions on areas of sun exposed skin - a phenomenon which is called field cancerization.
Zyclara - an imiquimod 3.75% cream - is to date the first clinically proven treatment option which can detect and eliminate subclinical as well as clinical AK lesions on large areas of the skin. Zyclara has shown in a large clinical development program to be an effective therapy in eliminating both kinds of AK lesions and with low recurrence rate.
“Zyclara represents a breakthrough product in actinic keratosis management and could transform how this disease is managed”, said Prof. Eggert Stockftleth, Professor of dermatology, Charité, Berlin and founder of the EpiDerm project which is sponsored by the European Union and has the aim to raise awareness of AK.
Based on press release

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