Following a recommendation by health officials, a new drug for peanut allergy – the first of its kind – has been approved in England.
The drug Palforzia is taken orally and will be available on the NHS to all eligible patients aged four to 17 by the middle of next year.
Peanut allergy is one of the most common food allergies in children and the most common cause of food allergy deaths. The allergy has doubled over the last two decades and is estimated to affect between 0.5% and 2% of children in the UK. In Europe and North America, more than 6 million people are affected, including up to 8% of children and 2-3% of adults. Although allergy to milk and egg are commonly outgrown by the age of 5-10 years, allergies such as to peanut are lifelong in 80-85% of cases and affect 2% of children and 1% of adults in high-income countries.
The unpredictable and potentially life-threatening nature of food allergic reactions is associated with substantial anxiety and impaired quality of life for patients.
Palforzia (made by Aimmune Therapeutics UK) contains precise and gradually increasing amounts of peanut protein. It works by gradually increasing the body’s ability to tolerate small amounts of peanut and can help reduce the severity of allergic reactions after being exposed to peanut.
The National Institute for Health and Care Excellence (NICE) approved the treatment after trials, called the Palisade and Artemis studies, at Evelina London Children's Hospital and Southampton Children’s Hospital showed repeated exposure over time to gradually increased doses of the allergen, could allow sufferers to increase their tolerance to peanuts. They would not be able to eat nuts at will, but their reactions could be reduced.
Professor Gillian Leng, chief executive at NICE said: “An allergy to peanuts can have a severe impact on the lives of children, young people and their families and carers. While it is rare for a peanut allergy to be fatal in the UK, the consequences of accidental exposure to peanuts can be severe, with some people needing to self-administer adrenaline and have emergency care if they are exposed to peanut.
“I am pleased that we’re able to recommend a treatment that could improve the quality of life for children and young people with a peanut allergy and their carers. It will also help to give their families or carers additional confidence their child will not have a severe reaction if they are exposed to peanut.”
Clinical trials showed that when compared with a placebo, Palforzia increased the proportion of people aged between 4 and 17 who could tolerate at least 1,000 mg peanut protein by over 50%. It is estimated 1,000 mg of peanut protein is equivalent to approximately 3 peanuts.
When people start taking Palforzia, they will need to attend a clinic which is able to treat anaphylaxis. If successful, people will then be able to up their dosing but will still need to attend a clinic each time the dose is raised.
Dr Mich Erlewyn-Lajeunesse, a Consultant in Paediatric Allergy at Southampton Children’s Hospital, and study investigator for the Palisade and Artemis trials, said: “Results from the phase 3 clinical trials and additional studies demonstrate the potential of Palforzia to mitigate against severe allergic reactions in the event of accidental exposure to peanut protein. As the first peanut allergy treatment available to patients on NHS England, today’s announcement is a very important milestone in our journey to bringing Palforzia to as many eligible patients across England as possible.”
Allergy campaigners said the drug has the potential to bring increased safety to people and families with a peanut allergy.
Anaphylaxis Campaign CEO Simon Williams said: “We know all too well that peanut allergy is extremely challenging and stressful for most children and teenagers with this condition. New treatment options are essential to mitigate the risk of potential severe allergic reactions due to accidental exposure.”