The company is developing AR101, an investigational biologic drug for use in oral immunotherapy as a treatment to reduce the frequency and severity of allergic reactions following exposure to peanuts.
Using only clinical data from the landmark phase 3 Palisade trial, Institute for Clinical and Economic Review found AR101 to be cost-effective than its traditional threshold of $100,000-$150,000 per quality-adjusted life year, or QALY, which measures the economic value of a health care intervention. When factoring in the societal perspective, ICER found AR101 to be even more cost-effective compared with avoidance alone.
"We have been working collaboratively with ICER over the last eight months to provide data about the strong value proposition of AR101 which, if approved, will be the first-ever treatment for peanut allergy," Aimmune Chief Executive Jayson Dallas said in a filing.
The US Food and Drug Administration's (FDA) Allergenic Products Advisory Committee is set to review Aimmune's Biologics License Application for AR101 on Sept. 13. The FDA accepted the BLA for AR101 in March and previously informed Aimmune that completion of its review would be targeted by late January 2020. The FDA granted AR101 Fast Track Designation in September 2014 and Breakthrough Therapy Designation in June 2015 for peanut-allergic children and adolescents ages 4 to 17.
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