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Aimmune wins over ICER for peanut allergy product

Analysts predict blockbuster status for first-in-class

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Aimmune is still a few months away from a potential US approval of its peanut allergy drug AR-101, but already has a thumbs up from the Institute for Clinical and Economic Review (ICER) on cost-effectiveness.

It’s an enviable position for a biotech striving to bring its first therapy to market, with ICER’s analysis concluding that the oral immunotherapy should fall well below its traditional threshold of $100,000-$150,000 per quality-adjusted life year (QALY).

Aimmune says ICER has concluded AR-101 is actually more cost-effective than simply avoiding peanuts when the broader societal costs of allergic reactions such as the effects on parents and caregivers are factored in.

Moreover, the analysis doesn’t include the most up-to-date phase 3 results and patients-reported outcome data with the drug, which could paint it in a more favourable light, it adds.

Aimmune took the decision to work closely with the ICER over the last few months in anticipation of the regulatory verdict on AR-101, which could become the first-ever treatment for the 1.6m people with peanut allergy in the US, and presented its case at an ICER meeting yesterday.

The FDA is due to deliver a verdict on the marketing application in January, somewhat delayed as it was caught up in the federal shutdown earlier this year, and an advisory committee meeting is expected to be convened before the end of this year.

Speaking on behalf of Aimmune at the ICER meeting, the company’s director of medical affairs Stephen Tilles – who is a board-certified allergist and immunologist – said that for two decades “avoidance has ruled the day, but it is the opposite of a patient-centred treatment because it often prevents children from living a normal childhood.”

Accidental exposures are “inevitable, traumatic, and can be fatal,” and that is reflected in surveys which show that 40% of teens believe they have a high likelihood of dying from accidental exposure to peanuts.

Analysts at GlobalData have suggested the market for peanut allergy products in eight major word markets could be worth $4.5bn in 2027.

Aimmune is currently leading the race to bring a peanut allergy therapy to market, after its main rival DBV Technologies decided to withdraw the marketing application for its Viaskin Peanut patch product last December after the FDA expressed concerns about manufacturing and quality control data.

DBV has said it intends to refile with the US agency in the third quarter of this year, so could be months behind Aimmune if the AR-101 review isn’t derailed. Meanwhile, Aimmune also seems to be in the lead in Europe, with a filing due in the next few months.

GlobalData predicts that Aimmune’s drug will have two thirds of the market in 2027, with DBV’s claiming around a third and other players such as Prota Therapeutics and Camallergy playing minor roles.

Article by
Phil Taylor

20th June 2019

From: Regulatory

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