|
REDWOOD CITY, Calif., Jan. 9 /PRNewswire-FirstCall/
-- Genelabs Technologies, Inc. announced today that the European
Agency for Evaluation of Medicinal Products (EMEA) has determined
that the Marketing Authorization Application (MAA) for Genelabs'
investigational lupus drug, Anastar(TM) (prasterone, Prestara(TM)
in the United States), is valid. Validation of the Anastar MAA indicates
that Genelabs' application is complete and that the review process
has begun. The application has been made under the European Union
Centralized Procedure which provides for simultaneous consideration
of the MAA in 17 European countries through a single centralized
review and decision.
Genelabs' MAA requests approval of Anastar for the
improvement of systemic lupus erythematosus (SLE or lupus) disease
activity and/or reduction in glucocorticoid doses in women with
active SLE. The application is based primarily on data from two
Phase III double-blind, randomized, placebo-controlled clinical
trials (studies GL94-01 and GL95-02) that together compared prasterone
to placebo in 572 women with mild to moderate lupus.
|
Message
Boards
