Market Quotes Powered By Forexpros, the Forex, Futures, and Stock Markets Portal.
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
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
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
“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
What do you think about this article and us? Please leave a comment!