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FDA expands Ryaltris to younger children with seasonal allergic rhinitis, Palforzia discontinues, and HAE's oral pipeline widens with deucrictibant and sebetralstat.
July brought major shifts across food allergy, hereditary angioedema (HAE), and allergic rhinitis care. Palforzia's discontinuation closed the chapter on the first FDA-approved peanut oral immunotherapy (OIT), while new omalizumab (Xolair) data reinforced a biologic alternative for multifood allergy.
Ryaltris (olopatadine/mometasone) — FDA approves seasonal allergic rhinitis treatment for children ages 6–11
Palforzia (peanut OIT) — FDA-approved peanut allergy oral immunotherapy discontinued July 31, 2026
Deucrictibant — FDA accepts NDA for oral hereditary angioedema (HAE) attack treatment
Neffy (epinephrine nasal spray) — Anaphylaxis guidelines still lag behind needle-free option
In HAE, sebetralstat (Ekterly) quality-of-life data and Pharvaris' deucrictibant NDA acceptance signaled a fast-maturing oral treatment landscape. Meanwhile, epinephrine nasal spray (neffy) guidance and an expanded Ryaltris (olopatadine/mometasone) pediatric indication rounded out a busy month for practicing allergists. Here are 6 allergy headlines you may have missed.
The FDA expanded Ryaltris (olopatadine hydrochloride/mometasone furoate, Glenmark Pharmaceuticals) to children aged 6 to 11 years with seasonal allergic rhinitis, extending the fixed-dose nasal spray beyond its original 2022 approval for patients aged ≥ 12 years. The expansion was supported by a phase 3 trial of 446 pediatric patients showing significant nasal symptom improvement over 14 days of twice-daily dosing versus placebo. Marc Kikuchi, president and business head, North America, at Glenmark Pharmaceuticals, called the approval a step toward broader pediatric access to combination antihistamine-corticosteroid nasal therapy.
Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp), the only FDA-approved peanut OIT, was permanently discontinued as of July 31, 2026, per manufacturer Stallergenes Greer. Approved in 2020 and originally developed by Aimmune before passing through Nestlé Health Science, Palforzia's exit leaves clinicians without an FDA-sanctioned OIT option for peanut allergy. Allergists Robert Wood, MD (Johns Hopkins), and Jacqueline Ross, MD (Allergy Partners of New Jersey), discussed what the loss means for patients currently in treatment and how practices should manage the transition, including counseling families on non-FDA-approved OIT protocols and biologic alternatives moving forward.
New OUTMATCH stage 2 trial data across 10 US academic centers showed omalizumab (Xolair) outperforming multiallergen OIT (MOIT) in patients with multifood allergy, addressing a gap left by the absence of prior head-to-head randomized comparisons. Trial investigator Robert A. Wood, MD (Johns Hopkins), reported a markedly low dropout rate among patients treated with the biologic. Omalizumab, FDA-approved in 2024 for reducing allergic reactions following accidental food exposure, now stands as 1 of only 2 approved food allergy therapies, alongside Palforzia, which exited the market this same month.
Related: Age, Maintenance Dosing Shape MOIT Counseling in Multifood Allergy
The FDA accepted Pharvaris' New Drug Application for deucrictibant immediate-release capsules, an oral bradykinin B2 receptor antagonist for on-demand HAE attack treatment, setting an April 23, 2027, PDUFA date. Phase 3 RAPIDe-3 data, drawn from > 1300 treated attacks, met its primary endpoint and all 11 secondary efficacy endpoints, with a median 1.28 hours to symptom relief onset. If approved, deucrictibant IR would become the first oral B2-antagonist option for acute HAE attacks, joining sebetralstat as an oral on-demand alternative to injectable therapies.
New KONFIDENT-S open-label extension data showed sebetralstat (Ekterly, KalVista Pharmaceuticals) delivered meaningful quality-of-life gains for patients with HAE already stable on long-term prophylaxis with berotralstat, lanadelumab, or C1 inhibitor replacement. Investigator Daniel Soteres, MD (Asthma & Allergy Associates), reported a 10.3-point improvement in Angioedema Quality of Life Instrument scores among 34 participants, with the largest gains in fatigue/mood, fears/shame, and functioning domains. Treatment satisfaction was high, with 88.8% of sebetralstat-treated attacks rated satisfactory, reinforcing oral on-demand therapy's role even in well-controlled patients.
Epinephrine nasal spray (neffy, ARS Pharmaceuticals) remains ahead of formal anaphylaxis practice parameters nearly 2 years after its initial approval. David Golden, MD (Johns Hopkins), co-chair of the 2023 anaphylaxis guideline update, told HCPLive that "guidelines don't happen overnight," leaving clinicians to interpret real-world use of the needle-free option without updated society recommendations. The gap highlights a common lag between novel drug approvals and formal guideline incorporation.
