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FDA to Hold Open Advisory Meeting on AR101 Peanut Allergy OIT Candidate
CBER will provide a live webcast of the committee meeting free of charge.
Aimmune Statement on Institute for Clinical and Economic Review (ICER) Final Report on AR101...
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.
Phase 3 Trial Data Demonstrates Consistent Safety and Efficacy of AR101 in Children and...
“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 Peanut Allergy
The FDA will review Aimmune's Biologics Licence Application for AR101 on September 13, 2019.
European Phase 3 Trial of AR101 Peanut OIT Candidate Meets Primary Endpoint
Company Intends to Submit European MAA in Mid-2019.
US FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut Allergy
If Approved, AR101 Will Be the First Medicine for This Life-Threatening Condition.
Aimmune Therapeutics Presents New AR101 Data Including Demonstrated Reduction in Accidental Exposures to Peanut...
AR101-Treated Patients Who Completed PALISADE Had 95% Increased Probability of Tolerating Any Dose of Peanut Protein in Exit Challenge Compared to Placebo.
Government Shutdown Delays Review of AR101 Peanut Oral Immunotherapy Candidate
The FDA has shelved consideration of the drug until funding is restored.
Aimmune Submits FDA Application to Offer AR101 for the Treatment of Peanut Allergy in...
“We have requested FDA Priority Review and look forward to working with the agency to bring what could be the first approved treatment in food allergy to patients as quickly as possible.”
Aimmune Therapeutics Announces Initiation of Phase 2 Study of AR101 With Adjunctive Dupilumab in...
Trial Will Build on the Positive, Pivotal Phase 3 PALISADE Trial of AR101.
