First drug to treat peanut allergies in children approved in US
The US has approved a drug which aims to eliminate peanut allergies in children aged four to 17.
The treatment, called AR101, will be sold under the brand name Palforzia.
The drug has been designed to gradually reduce sensitivity to peanuts by exposing patients to a highly-refined version of peanut flour over the course of several months.
The oral treatment will be the first to offer relief from peanut allergy symptoms for those who previously had to avoid all contact with the nuts in any form, or risk a reaction requiring emergency treatment with an EpiPen or another epinephrine shot.
The US Food and Drug Administration (FDA) approved the treatment on Friday.
The drug has not yet been approved in the UK.
Aimmune Therapeutics Inc, which makes the drug, has said the aim is to get allergic children and teens to the point where accidental exposure to small amounts of peanuts do not trigger a potentially life-threatening immune response.
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Peanut allergies are the leading cause of death from food-induced allergic reactions in the US, with symptoms ranging from red, swollen skin to potentially deadly airway constriction.
Peanut allergy could be beaten by building up tolerance, study finds
The FDA-approved label for Palforzia includes a warning of its potential to trigger a possibly dangerous allergic response.
Aimmune said each dose increase will be done under the supervision of an allergist who is prepared to treat an allergic reaction that arises.
The company has priced the treatment at $890 (£674) a month, but the list price of a drug is not necessarily what patients actually pay.
Aimmune has said some 1.6 million US children aged four to 17 live with peanut allergies, creating for an opportunity for peak annual sales in excess of $1bn (£757m).
The FDA approval comes months after an independent panel of experts backed the allergy therapy but raised concerns about the risk of severe allergic reactions it poses to young patients.
The drug may soon face competition from French drugmaker DBV Technologies SA, which has filed for US approval of a once-daily skin patch to reduce sensitivity to peanut exposure.
The FDA is expected to make its approval decision for DBV’s Viaskin Peanut patch by August 2020.