Friday, March 16, 2012

Novartis - Interim update on EU regulatory review on Gilenya

Novartis has annoucned today that EMA will issue the final recommendation on the MS drug Gilenya in April, while the interim recommendation for increased monitoring of patients remains unchanged. Novartis has also announced that it is working with the CHMP to finalize the label and supporting materials.
The tone of today's announcement seems to hint that Gilenya would face some label changes.The REMS may become more strict and the label may include some contraindications or restrictions on use