Allergic Disorders

Bacterial pneumonia treatment now available; FDA deny anaphylaxis treatment; flu vaccine efficacy results; flexible dosing for Talicia; change in the therapeutic equivalence for organ rejection drug generic. 

Given the new requirement, ARS expects to resubmit the NDA for neffy in the first half of 2024.

Remibrutinib is an investigational oral Bruton tyrosine kinase inhibitor

Guideline awareness and primary care provider encouragement are significant drivers of early introduction.

Suspected cases mainly occur in counties within the Southern, Midwestern, and Mid-Atlantic US Census Bureau regions.

Direct oral challenge noninferior to skin testing followed by oral challenge for patients with low-risk allergy.

First over-the-counter birth control pill; expanded approval for Leqvio; Gavreto has an indication withdrawn; batches of Albuterol inhalers recalled; results from analysis of paclitaxel-coated devices.

Findings for randomized trial of consumption in early neonatal period and allergy development at 12 months.

Neffy is an intranasal formulation of epinephrine.

The phase 3 INVIGORATE-2 trial included 131 allergic conjunctivitis patients 18 years of age and older.

The study included 1458 children aged 5 to 11 years with a clinical history of HDM-induced allergic rhinitis.

Intranasal epinephrine was found to be well tolerated with no significant nasal pain or irritation.

Significantly more children aged 1 to 3 years receiving epicutaneous immunotherapy had treatment response at 12 months.

Neosalus Cream, Lotion Available Again for Management of Various Dermatoses

Subset of alpha-gal allergic patients show gastrointestinal symptoms without skin changes or anaphylaxis.

The sBLA is supported by data from Studies A and B of phase 3 LIBERTY-CUPID trial which included patients with CSU who were inadequately controlled on standard-of-care H1 antihistamines.

Updated review reveals supplementation does not impact rate of exacerbations requiring systemic corticosteroids

18.9 percent of children and 25.7 percent of adults had seasonal allergy; 10.8 and 7.3 percent had eczema in 2021

Odactra is an allergen extract indicated as immunotherapy for the treatment of HDM-induced allergic rhinitis.