European Commission approves EU’s first peanut allergy treatment
pharmafile | December 21, 2020 | News story | Sales and Marketing | Aimmune, European Commission, allergy
Aimmune Therapeutics today announced that the European Commission (EC) has approved PALFORZIA as the EU’s first-ever treatment of peanut allergy.
The treatment is indicated in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy in conjunction with a peanut-avoidant diet, and may be continued in patients 18 years of age and older.
Phase III clinical trials showed that more than half of patients treated with PALFORZIA were able to tolerate the equivalent of seven to eight peanut kernels after up to nine months of treatment, highlighting the drug’s potential to mitigate against severe allergic reactions, including anaphylaxis in the event of unintended exposure to peanut protein.
Food allergies affect around 17 million people across Europe, with peanut allergy being one of the most common. The incidence of hospital admissions due to severe allergic reactions increased seven-fold between 2005 and 2015, and around two-thirds of schools in Europe have at least one child at risk of anaphylaxis.
Analyses in multiple European countries estimate that around 1.6% of European children live with peanut allergy, with estimations ranging from 0.24% to 2% depending on the diagnostic methods used. Severe reactions, which can be life threatening, and the difficulty of avoidance create an urgent need for treatment.
Andrew Oxtoby, President and CEO of Aimmune Therapeutics, said: “Today’s approval is a historic moment for the millions of people living with potentially life-threatening peanut allergy, and we are proud to bring PALFORZIA to patients in the EU who, until now, have not had an approved therapeutic option.
“We are grateful for the efforts of the peanut allergy community who contributed to the development program. Now we turn our efforts toward working with health authorities to ensure access of this first-of-kind treatment for those children with peanut allergy for whom our product is appropriate as we prepare to launch in Germany and the UK in May 2021.”
Darcy Jimenez
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