1. Pink Sheet
  2. >>Product Reviews
  3. >>Complete Response Letters

April User Fee Goal Calendar: Forecast Uncertain For Atopic Dermatitis Candidates, Nuplazid; Eohilia Could Be First For Orphan Use

 
• By Bridget Silverman

While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.

Shutterstock - 661293361 Rain falling and colorful umbrella in rainy day
Sponsors could be showered with a range of approvals in April. • Source: Shutterstock

April could be a good month for people with atopic dermatitis, with US FDA decisions due on three applications – all hailing from the well-known JAK inhibitor class, two designated breakthrough therapies – unless emerging class safety concerns spur major amendments and consequent three-month extensions to the user fee goal date.

The expanding empire of JAK inhibitors in immune-mediated disease is poised to move into the large atopic dermatitis, or eczema,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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?

More from Complete Response Letters

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By Sue Sutter

The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

More from Product Reviews

Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

 
• By Neena Brizmohun

Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
• By Bridget Silverman

US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.