Novartis will have to wait a bit longer in its bid to get the first oral treatment for multiple sclerosis on the market after regulators in the USA put back a review of Gilenia.

The US Food and Drug Administration has extended by three months, to September, its review period for Gilenia (fingolimod), previously known as FTY720. A meeting of the agency's Peripheral and Central Nervous System Drugs Advisory Committee remains scheduled for June 10 to discuss the benefit/risk profile of the drug but the agency but the extension is based on the FDA's request for further analysis of available data.

Novartis has responded to that request for more data on Gilenia, which was granted priority review status in February this year, reducing the standard 10-month review period to six months.That was set to end on June 21, but this latest development has triggered the three-month extension.

The Swiss major notes that the agency did not ask for additional clinical trials and head of pharma development Trevor Mundel said the revised timeline “is in line with our expectations, and reflects the comprehensive clinical programme and resulting large amount of data to be reviewed”.

Novartis is up against Merck KGaA in a race to be the first firm with an approved MS oral treatment. At the end of last year, the German drugmaker was hit with a setback after US regulators issued a ‘refuse to file’ letter for cladribine, indicating that the New Drug Application for the treatment is incomplete.