Aimmune Statement on Institute for Clinical and Economic Review (ICER) Final Report on AR101 for Peanut Allergy
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
The resulting final report is biased against immunotherapy, generally, and fails to specifically capture the full value of AR101. Aimmune joins advocates and clinical experts asking payers and policymakers to engage in more thoughtful, unbiased consideration of available evidence—including patient perspectives on quality-of-life improvements and relief from the stress and fear of accidental exposure—when evaluating emerging treatments for peanut allergy.
In clinical trials, AR101, Aimmune’s investigational biologic drug for use in oral immunotherapy, has demonstrated the ability to increase the median tolerated dose of peanut protein by 100-fold in each of its two pivotal Phase 3 clinical trials. While the report found AR101 to be cost-effective well below traditional health economic thresholds, ICER failed to acknowledge the availability of the positive long-term efficacy and quality-of-life data from the PALISADE open label follow-on study, as well as the clinical outcomes data from the European Phase 3 ARTEMIS trial. These data were recently presented at the 2019
“From the onset, we have believed that ICER’s attempt to assess the value of AR101 was premature, based too heavily on theoretical discussions rather than real-world insight, and omitted valuable patient perspective. Critical data from our Phase 3 trial program continues to emerge, specifically new patient-reported quality-of-life data that were excluded from the analysis,” said
Additionally, ICER failed to consider the potential for long-term disease modification consistent with allergen immunotherapies and mischaracterized the allergic response associated with immunotherapy as a harm, rather than an expected, well understood and easily managed part of the immunotherapy process. With all immunotherapy, allergic reactions are expected and acceptable in the short term in exchange for long-term desensitization to protect against accidental exposure. In clinical trials, median tolerated dose for AR101-treated patients improved from 10mg at baseline to 1000mg at month 12 to 2000mg at month 18—demonstrating both the potential for long-term disease modification and the potential for significant protection against the average real-world reaction-provoking exposure of 125mg, or half a peanut.
“The peanut allergy community, including patients, families, advocates and allergists, are well aware of and well prepared for the possibility of reactions as part of the shared decision-making process involved in immunotherapy,” said
AR101 is a new, peanut-derived investigational oral biologic drug for use in oral immunotherapy in patients with peanut allergy. The drug, which is manufactured in accordance with current Good Manufacturing Practices (cGMP), delivers a daily dose of peanut protein with a characterized protein profile, analyzed to ensure consistent major allergen content. The amount of active ingredient in each AR101 capsule is controlled to ensure minimal variability of allergen content across doses of a given strength. AR101 is administered as an oral powder in graduated doses in pull-apart capsules or foil-laminate sachets. The contents are mixed thoroughly with a few spoonfuls of age-appropriate, unheated food of the patient’s choice.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune’s expectations regarding the potential benefits of AR101, including quality-of-life improvements and relief from the stress and fear of accidental exposure; Aimmune’s expectations regarding the potential ability of AR101 to effect meaningful desensitization, long-term disease modification and significant protection against real-world exposure; Aimmune’s expectations regarding the timing and completion of the review of the BLA for AR101 by the
This press release concerns AR101, a product candidate that is under clinical investigation, and AR201, a product candidate that Aimmune expects will be under clinical investigation in 2019. Neither AR101 nor AR201 has been approved for marketing by the