Tag: AR101
FAQ for Palforzia, the First FDA Approved Therapy for Food Allergy
What it is, what it treats, who it is for, how it is used, et al.
FDA to Hold Open Advisory Meeting on AR101 Peanut Allergy OIT...
CBER will provide a live webcast of the committee meeting free of charge.
Fare Responds to Final ICER Review of Breakthrough Peanut Allergy Therapies
FARE expresses its deep concerns with the final evidence report on two breakthrough peanut allergy therapies issued Wednesday by ICER.
Asthma and Allergy Foundation of America Responds to Premature ICER Review...
The AAFA addresses concerns
regarding the Final Evidence Report released by the ICER.
Aimmune Statement on Institute for Clinical and Economic Review (ICER) Final...
Exclusion of long-term desensitization and patient quality-of-life data by ICER fails to recognize the full value AR101 immunotherapy can deliver to the peanut allergy community.
ICER’s Final Report on Peanut Allergy Treatments: Clinical Evidence Does Not...
The report evaluates Viaskin® Peanut and AR101, as well as non-commercialized oral immunotherapy (OIT).
Asthma and Allergy Foundation of America Elevates Patient Voice in ICER...
Affirms Burden of Food Allergies on Families, Patients, and Caregivers.
Joint Statement on Peanut Allergy Therapy Review
Organizations representing patients and allergists urge ICER to adopt a more patient-driven approach to assessing immunotherapies for peanut allergy.
Phase 3 Trial Data Demonstrates Consistent Safety and Efficacy of AR101...
“Results of the European ARTEMIS trial provide further clinical validation of the safety and efficacy of AR101 for children and adolescents with peanut allergy.”
Aimmune Announces US FDA Advisory Committee Meeting Date for AR101 for...
The FDA will review Aimmune's Biologics Licence Application for AR101 on September 13, 2019.
