1. Pink Sheet

Regulatory Flexibility: BrainStorm’s Problematic NurOwn BLA May Be A Bridge Too Far For US FDA

 
• By Sue Sutter

Litany of deficiencies, including product quality shortcomings and a failed Phase III clinical efficacy study, may make it impossible for the agency to exercise the type of flexibility it has with the approval of other treatments for ALS and neurodegenerative diseases.

Separate ways
The litany of problems with NurOwn may force the FDA to take a different path than it has with recently approved ALS drugs. • Source: Shutterstock

At the 27 September advisory committee review of BrainStorm Cell Therapeutics Inc.’s NurOwn (debamestrocel), company representatives and their experts, along with amyotrophic lateral sclerosis patients and advocates, urged the US Food and Drug Administration to exercise the same kind of regulatory flexibility it has used to approve treatments for ALS and other neurodegenerative diseases in recent years.

However, NurOwn, which comprises autologous bone marrow-derived mesenchymal stromal cells induced to secrete neurotrophic factors (MSC-NTF), may be the proverbial bridge too far, exceeding the outer bounds of regulatory flexibility for an agency that has granted,

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 US FDA Performance Tracker

More from Regulatory Trackers