FDA Approves U.S. Pediatric Indication Extension for Palforzia® Oral Immunotherapy for the Treatment of Peanut Allergy
30 Julio 2024 - 5:09AM
Business Wire
Stallergenes Greer, a leading global healthcare company
specialising in allergen immunotherapy, today announced that the
U.S Food and Drug Administration (FDA) has approved Palforzia®
[Peanut (Arachis hypogaea) Allergen Powder-dnfp], for the treatment
of toddlers (ages 1-3 years) with a confirmed diagnosis of a peanut
allergy. This approval expands the January 2020 FDA approval for
patients ages 4-17 years. Palforzia® is to date the first and only
approved oral immunotherapy treatment (OIT) for the mitigation of
allergic reactions, including anaphylaxis, that may occur with
accidental exposure to peanut.
Peanut allergy currently affects approximately 2% of the general
population of Western nations1, and the prevalence of peanut
allergy doubled among children between 2005 and 20152. Compared
with other food allergies, peanut allergy is associated with higher
rates of accidental exposure, severe reactions and potentially
fatal anaphylaxis1. The difficulty in avoiding peanuts, combined
with the severity of allergic reactions, shows the need for
effective treatment3.
“We are delighted that Palforzia® has received regulatory
approval in the U.S. for toddlers as there is a high unmet medical
need for this age group and we are confident that this indication
extension will alleviate the burden of peanut allergy for younger
patients and their families,” says Elena Rizova, MD, PHD, Chief
Medical Officer of Stallergenes Greer.
The FDA approval in toddlers is based on data from the Phase 3
POSEIDON (Peanut Oral Immunotherapy Study of
Early Intervention for Desensitization)
study that was published in the New England Journal of Medicine
Evidence in 2023. The study evaluated the efficacy and safety of
Palforzia® in peanut-allergic children aged 1 to 3 years old,
meeting all its primary and secondary efficacy endpoints and
demonstrating a favourable safety profile.
Stallergenes Greer acquired the rights to Palforzia® in
September 2023. As part of our ongoing commitment to delivering
innovative solutions in allergen immunotherapy, our focus in the
U.S has been on establishing a specialised Food Allergy business
unit and transitioning the product into our AIT portfolio.
ABOUT PALFORZIA®
Palforzia® is in the U.S an oral immunotherapy treatment
indicated for the mitigation of allergic reactions, including
anaphylaxis, that may occur with accidental exposure to peanut for
patients. The treatment is approved for use in patients with a
confirmed diagnosis of peanut allergy and in conjunction with a
peanut-avoidant diet. Limitation of Use: Not indicated for the
emergency treatment of allergic reactions, including
anaphylaxis.
Palforzia® is approved by the U.S. Food and Drug Administration
(FDA) for ages 1-17 years and for ages 4-17 years by the European
Medicine Agency (EMA), by the Medicines and Healthcare products
Regulatory Agency (MHRA) in the U.K., and by Swissmedic in
Switzerland. Pediatric indication extension submissions are
currently under review by the EMA and Swissmedic.
ABOUT POSEIDON PHASE 3 STUDY
POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention
for Desensitization, clinicaltrials.gov number NCT03736447) is an
international, randomized (2:1), double-blind, placebo-controlled
Phase 3 study that evaluated the efficacy and safety of Palforzia®
in peanut-allergic children aged 1 to 3 years of age in North
America and Europe.
The POSEIDON study was completed by Aimmune Therapeutics, part
of Nestlé Health Science before Nestlé divested Palforzia® to
Stallergenes Greer in September 2023.
Enrollment was based on several entry criteria, including a
documented clinical history of peanut allergy, positive skin prick
tests and/or elevated blood levels of peanut antibodies, and
dose-limiting symptoms after consuming single doses of peanut
protein >3 to ≤300 mg in a positive double-blind,
placebo-controlled food challenge.
In POSEIDON, patients underwent a dose-escalation period of
approximately 22 weeks to reach a dose of 300 mg per day of
Palforzia® or placebo, then continued that dose for approximately
six months. At the end of the trial, patients underwent an exit
double-blind, placebo-controlled food challenge (DBPCFC).
ABOUT STALLERGENES GREER INTERNATIONAL AG
Headquartered in Baar (Switzerland), Stallergenes Greer
International AG is a global healthcare company specialising in the
diagnosis and treatment of respiratory, food and venom allergies
through the development and commercialisation of allergen
immunotherapy products and services. Stallergenes Greer
International AG is the parent company of Greer Laboratories, Inc.
(whose registered office is in the United States) and Stallergenes
SAS (whose registered office is in France). For more information,
visit www.stallergenesgreer.com.
1 The global burden of illness of peanut allergy: A
comprehensive literature review. Jay A. Lieberman, Ruchi S Gupta,
Rebecca C. Knibb, Tmirah Haselkorn, Stephen Tilles, Douglas P.
Mack, and Guillaume Pouessel. Online:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247890/ Accessed
August 31, 2023 2 Du Toit G, et al. Randomized Trial of Peanut
Consumption in Infants at Risk for Peanut Allergy. N Engl J Med
2015; 372: 803-13. Accessed August 31, 2023. 3 Bock SA,
Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic
reactions to foods. J Allergy Clin Immunol. 2001;107:191-3.
Accessed August 31, 2023.
Palforzia®: © 2023, Société des Produits Nestlé S.A. or its
affiliates
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Stallergenes Greer Communications Catherine Kress Tel:
+33 (0)1 55 50 26 05 Email:
catherine.kress@stallergenesgreer.com