Singapore, Feb 22, 2010: Gilenia has been granted priority review status by the US Food and Drug Administration (FDA), which accepted the regulatory submission made in December 2009 for this medicine. Once-daily Gilenia  (0.5 mg) has the potential to become the first approved oral therapy for the treatment of multiple sclerosis (MS).

The FDA grants priority reviews for investigational medicines that could offer significant advances beyond current treatments or where no adequate therapy exists. As a result of this designation, the standard 10-month FDA review period will be reduced to six months.

Since Gilenia involves a new active ingredient (New Molecular Entity), the FDA is likely to require an Advisory Committee meeting and evaluate the risk management program, which could result in the FDA extending its review at the end of the six-month period in June 2010.

"We welcome the decision granting priority review to Gilenia, which underscores the potential benefits of this medicine to patients," said Trevor Mundel, Global Head of Development at Novartis Pharma AG. "MS is a leading cause of neurological disability in young adults, particularly in women, and this medicine has the potential to offer real advances in the care of people with MS."