Patience Pays Off For Kyowa Kirin As Nourianz Finally Gets US FDA OK

The Japanese firm's original 2007 NDA was rejected in 2008 but it kept faith in the drug, now approved as an adjunct to levodopa/carbidopa. At least one competitor is waiting in the wings.

Parkinsons Disease
Nourianz is a levodopa/carbidopa add-on to treat "off" episodes. • Source: Shutterstock

Kyowa Kirin Co. Ltd. never gave up on Nourianz (istradefylline) for Parkinson's disease (PD) and now the company's patience has paid off with US Food and Drug Administration approval on 28 August for the adenosine A2A receptor antagonist – the first drug approved in its class for PD.

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

More from New Products

Pipeline Watch: Ten Approvals And Eleven Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch: 13 Approvals And 13 Phase III Trial Updates

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Vanrafia Approval Plays Into Novartis’s Multipronged IgAN Approach

 

The approval of another Novartis drug with a different mechanism means the company is further cornering multiple parts of IgAN pathogenesis.

Orphans Cling On To Growth Advantage As Market Share Heads Towards 20%

 

It might be the beginning of the end for the orphan drugs party but there is still sales growth enjoyment to be had for the sector, whose star performers are now looking increasingly like mainstream drugs.

More from Scrip

Disappointing Asthma Phase II Results Take Wind Out Of Sanofi’s Amlitelimab

 

Sanofi’s OX40L candidate missed a Phase II primary endpoint, but the company believes it can still work in a sub-group of ‘heterogeneous inflammatory asthma’ patients.

Stock Watch: Disappointing ACC Share Price Reactions For AstraZeneca And Lilly

 
• By 

The end of the American College of Cardiology conference was a prelude to a volatile trading week for most stocks. Even before Liberation Day, reactions to the conference announcements were not encouraging.

Korean Biotech Roundup: GNT Set For First Direct Korean Biopharma IPO On Nasdaq

 
• By 

GNT Pharma prepares for the first listing of a Korean biotech on Nasdaq, while others sign major global out-licensing deals with large multinational partners.