Tag: AR101

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.”
Peanuts

Non-Profit Institute to Review Benefits of Commercial, Private Practice Immunotherapies for...

An independent review of the value, costs and effectiveness of Viaskin Peanut, AR101, and private practice peanut OIT.
AR101

New Treatment to Protect People with Peanut Allergies Ready for FDA...

"Two thirds of the people in the study were able to tolerate the equivalent of two peanuts per day after 9 to 12 months of treatment."
AR101+dupilumab

Aimmune Therapeutics Announces Initiation of Phase 2 Study of AR101 With...

Trial Will Build on the Positive, Pivotal Phase 3 PALISADE Trial of AR101.
AR101+dupilumab

Phase II Trials of AR101 with Dupilumab for Peanut Allergy to...

Study scheduled to commence next week.
AR101

Peanut OIT Phase 3 Trial Results Show Therapy Effective for Ages...

Aimmune plans to submit a Biologics License Application for AR101 to the FDA by the end of 2018.
AR101

Aimmune to Submit FDA Application for Peanut OIT Candidate by End...

If approved, AR101 could be offered as the first FDA approved OIT therapy for peanut allergy.
AR101

Results of Phase III Trial of Aimmune’s Peanut OIT Therapy

After one year, 3/4 of patients ages 4-17 who received the therapy were able to consume a minimum of 300mg of peanut. Results for adults were less clear.
AR101

Aimmune Issues Update on AR101 Peanut Oral Immunotherapy Candidate

The company announces their timeline for continued progress toward an FDA approved standardized therapy.

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