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Find Clinical Drug Pipeline Developments & Deals by Aimmune Therapeutics
Palforzia (arachis hypogaea) is an oral immunotherapy (OIT) for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy.
Self-and caregiver proxy-reported total scores on the FAQLQ for PALFORZIA (arachis hypogaea allergen powder-dnfp)-treated participants generally improved at trial exit from baseline; change in total scores on the FAIM improved throughout all trials.
Data presented at the meeting suggest that continued long-term treatment with PALFORZIA induced long-term immunomodulation, indicating a continued shift away from pretreatment sensitivity to peanut.
Lead Product(s):
Arachis Hypogaea Allergen Powder-dnfp
PALFORZIA can be readily implemented in clinical settings for the treatment of PA. Results show that PALFORZIA treatment was successfully incorporated in practice by health care providers without prior OIT experience.
Lead Product(s):
Arachis Hypogaea Allergen Powder-dnfp
The analysis showed that peanut-allergic patients ages 4 through 17 who continued daily maintenance with PALFORZIA for up to two years were able to tolerate higher doses of peanut during the food exit challenge.
Lead Product(s):
Arachis Hypogaea Allergen Powder-dnfp
Patient-reported treatment satisfaction was evaluated over two years following daily treatment with PALFORZIA in a clinical trial setting using the Treatment Satisfaction Questionnaire for Medication (TSQM-9).
Lead Product(s):
Arachis Hypogaea Allergen Powder-dnfp
In patients with peanut allergy who continued daily treatment with PALFORZIA for up to 3.5 years reported adverse events were mostly mild, occurred early on in treatment, and declined over the course of treatment.
Lead Product(s):
Arachis hypogaea allergen powder-dnfp
The approval was based on a package of data, including from two phase 3 clinical trials PALISADE and ARTEMIS. In both studies, PALFORZIA treatment resulted in a significant increase in the amount of peanut protein tolerated, compared to placebo.
ARTEMIS met all primary, secondary and safety endpoints, and demonstrated that patients treated with PALFORZIA experienced a high degree of desensitization to peanut with an anticipated and manageable safety profile.
Aimmune's recently approved therapy Palforzia® would expand Nestlé Health Science portfolio with first and only FDA-approved treatment to help reduce the frequency and severity of allergic reactions to peanuts in children.
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