1. Scrip
  3. >>Clinical Trials

Aimmune Accelerates Commercial Planning For Peanut Allergy Drug

 
• By Emily Hayes

Even better than expected efficacy and safety in the Phase III PALISADE trial puts Aimmune on track to file its BLA for peanut protein capsule AR101 by the end of 2018.

SC1802_Peanuts_1026503161_1200.jpg

Aimmune Therapeutics Inc.says it is planning to "significantly accelerate" its launch planning for the oral peanut protein capsule AR101 now that it has positive data in hand from the Phase III PALISADE study in allergic children and adolescents aged 4 to 17. 

More than 2.2m children in the US have a peanut allergy and nothing is approved to prevent severe reactions, though epinephrine is available to reverse potentially deadly reactions. With that in mind, the US FDA granted AR101 breakthrough therapy and fast track designations for desensitization of peanut-allergic patients ages 4-17, and now Aimmune plans to submit a biologic license application (BLA) to the agency before the end of 2018 based on PALISADE's positive results announced Feb. 20

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?

More from Clinical Trials

More from R&D

Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By Kevin Grogan

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 
• By Alaric DeArment

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 
• By Andrew McConaghie

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.