Tag: AR101

AAFA Press Release Regarding ICER Review

Asthma and Allergy Foundation of America Elevates Patient Voice in ICER...

Affirms Burden of Food Allergies on Families, Patients, and Caregivers.
FARE-ACAAI-AAN Statement

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.
AR101

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.”
AR101

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.
OIT

Leading Allergists, Researchers and Food Allergy Advocates to Discuss State of...

The summit intends to address the risks and benefits of OIT, OIT implementation in practice and the gaps in knowledge about OIT to enable physicians to have a better understanding of this therapy and to help patients make fully-informed choices about treatment options.
AR101

European Phase 3 Trial of AR101 Peanut OIT Candidate Meets Primary...

Company Intends to Submit European MAA in Mid-2019.
AR101

US FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut...

If Approved, AR101 Will Be the First Medicine for This Life-Threatening Condition.
AR101

Aimmune Therapeutics Presents New AR101 Data Including Demonstrated Reduction in Accidental...

AR101-Treated Patients Who Completed PALISADE Had 95% Increased Probability of Tolerating Any Dose of Peanut Protein in Exit Challenge Compared to Placebo.
AR101 Delayed by Gov't Shutdown

Government Shutdown Delays Review of AR101 Peanut Oral Immunotherapy Candidate

The FDA has shelved consideration of the drug until funding is restored.
AR101

Aimmune Submits FDA Application to Offer AR101 for the Treatment of...

“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.”

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