Surprise Knockback For Safinamide Gives Azilect A Boost

Just days after US WorldMeds signed up to commercialize the Parkinson's disease add-on therapy Xadago (safinamide) in the US, with US approval anticipated on its Mar. 29 PDUFA date, the product has been turned back by the FDA. The agency wants evaluation of the oral, once a day drug for its abuse liability and dependence/withdrawal effects before it can be approved, it said in a complete response letter.

Just days after US WorldMeds signed up to commercialize the Parkinson's disease add-on therapy Xadago (safinamide) in the US, with US approval anticipated on its Mar. 29 PDUFA date, the product has been turned back by the FDA. The agency wants evaluation of the oral, once a day drug for its abuse liability and dependence/withdrawal effects before it can be approved, it said in a complete response letter.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

Zai’s R&D Head Touts ‘Beauty’ Of Novel Internal Assets

01 May 2025

• By Dexter Jie Yan

Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.