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Aimmune gets FDA panel backing for peanut allergy therapy

Step closer to becoming first approved treatment


Aimmune’s AR101 has moved a step closer to becoming the first approved peanut allergy treatment in the US after an FDA advisory committee voted in favour of its approval.

The panel voted seven to two that AR101 – now given the trade name Palforzia – can reduce allergic reactions from accidental exposure to peanuts and warrants approval.

Eight of the specialists also agreed that the oral immunotherapy was safe, which is a relief to the company as FDA briefing documents published ahead of the meeting highlighted that patients treated with it were more likely to suffer systemic allergic reactions than those on placebo.

The FDA is due to make a decision on AR101 in January, and usually, but not always, follows the advice of its clinical advisors. Aimmune has also been filed for approval in Europe, with a verdict due next year.

If it is granted approval, AR101 would be the first treatment to become available for the estimated 1.6 million people with a peanut allergy in the US, who at the moment have to rely on avoidance strategies to prevent accidental exposure. Peanut allergies are the leading cause of death from food-induced allergic reactions in the US.

The immunotherapy consists of defatted peanut flour that is sprinkled over food and is designed to train the immune systems of people with peanut allergy to develop a tolerance to the antigens that cause potentially life-threatening reactions.

The FDA reviewer noted in the briefing document that 12 patients treated with AR101 were diagnosed with eosinophilic esophagitis, while there were no cases in the placebo group, although panellists heard this was manageable and resolved when treatment stopped.

Other allergic-type reactions to the therapy included abdominal discomfort or pain, coughing, hives, itching, nausea, throat irritation and vomiting.

The experts also discussed the possibility that the immunotherapy might lull people into thinking they were fully protected and compromise avoidance, although Aimmune recommends no change to avoidance strategies even if treatment is working.

Analysts think approval is likely, perhaps with a black box warning to emphasise the risks of unexpected allergic reactions to AR101 product itself, and think it could easily reach blockbuster sales levels.

California-based Aimmune already has an endorsement from the Institute for Clinical and Economic Review (ICER) on price, with the cost-effectiveness organisation saying recently that it was cost-effective at the proposed price of between $5000 to $10,000 for the first six months of use, and $300 to $400 per month thereafter.

Analysts at GlobalData have suggested the market for peanut allergy products in eight major world markets could be worth $4.5bn in 2027, with Aimmune claiming a two-thirds share ahead of rivals including DBV Technologies which has a patch-based immunotherapy product in late-stage development.

DBV was forced to withdraw the US marketing application for its Viaskin Peanut patch product last December after the FDA expressed concerns about manufacturing and quality control data. It refiled for approval last month.

Article by
Phil Taylor

16th September 2019

From: Regulatory



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