This site is intended for health professionals only!
Two Aeterna Zentaris (AZ) cancer treatments look set to receive EU approval in the near future after the regulator responded positively to ongoing trials.
AZ said the European Medicines Agency (EMEA) had indicated that tests on Perifosine and Velcade, both used for multiple myeloma, were sufficient “to provide all data necessary to support a marketing authorization”.
The judgement comes after the company asked the EMEA for its opinion on the acceptability of the trials, which are being sponsored by Keryx Biopharmaceuticals.
Perifosine was given fast-track status, allowing for rapid approval, as a colorectal cancer treatment by the FDA earlier this month. It received an identical designation for use as a myeloma drug late last year.
Company officials said they hoped American authorisation would support an application for approval in Europe and the rest of the world.
Copyright Press Association 2010