Tag: Aimmune Therapeutics

AR101

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 Reponse to ICER Report

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.
AAFA Reponse to ICER Report

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 Reponse to ICER Report

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 Final Report

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).
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.
Anxious Teen

Study: Over Half of Teens with Peanut Allergy Visited the ER,...

4 in 10 Teens believe they have a great or very great chance or certainty of dying from accidental exposure.
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.
AR101

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

Company Intends to Submit European MAA in Mid-2019.

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