FDA approves new PD drug Xadago

In a U-turn by the US agency, the Food and Drug Administration on Tuesday approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.

Xadago, the first new Parkinson’s drug to be cleared for marketing in the USA for more than a decade, is being commercialized by Italian drugmakers Newron Pharmaceuticals (NWRN: SIX) and Zambon, along with the latter’s partner US WorldMeds, which will be responsible for marketing the drug in the USA, at a list price without insurance of $670 for a 30-day supply of either the 50mg or 100mg dose.

Parkinson’s disease affects an estimated 7 to 10 million patients worldwide, of whom 1 million are in the USA. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking.

The FDA rejected Xadago last year, but later said that clinical studies to evaluate the potential abuse liability or dependence/withdrawal effects of the drug were no longer required.