Allergy

The FDA approval of neffy 1 mg follows the earlier approval of the 5 mg version in August 2024.

AAAAI 2025: Data from the ANCHOR-1 and ANCHOR-2 phase 3 trials show improvements in nasal polyp size and obstruction for depemokimab with twice-yearly dosing vs placebo.

The impact of food elimination diets on medication previously was unknown, according to new research presented at AAAAI 2025.

Safety findings from the phase 3 OUtMATCH trial were notable, including no adverse events for omlizumab vs 30.5% for OIT and epinephrine use for 0% vs 37.3%, respectively.

Participants (aged 6 to 17 years) receiving neffy vs standard treatments had fewer skin, gastrointestinal, and respiratory symptoms at 15, 5, and 5 minutes, respectively.

AAAAI 2025: Dupilumab was associated with a 56.9% reduction in IgE levels at 12 months and of 73.5% at 24 months, according to results presented at AAAAI 2025.

AAAAI 2025: Phase 2 study results showed POIT with home-measured peanut products was not only highly effective but also posed few risks.

Data on the epinephrine nasal spray will include findings from an efficacy study comparing anaphylaxis symptoms during oral food challenge, according to ARS.

In a randomized clinical trial, omalizumab achieved a 36% treatment success rate for multi-food allergy compared with 19% for oral immunotherapy.

AAAAI 2025. Treatment response rates with daily use of the VIASKIN peanut patch increased from 39% at baseline to 73.3% at 60 months in youth aged 4 to 11 years.

Researchers at Phoenix Children’s Hospital conducted one of the largest real-world clinical evaluations of the esophageal string test in children.

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If approved, neffy 1 mg will be the only needle-free epinephrine treatment available for the younger, school-aged population.

Treatments with the investigational rescue medication achieved clinically effective epinephrine levels faster than intramuscular injection.

The updated guidelines include 19 recommendations related to the diagnosis and management of eosinophilic esophagitis.

Aquestive Therapeutics announced positive feedback from the FDA this week that keeps NDA planning for the novel epinephrine product on solid ground.

The target action date for the FDA decision is April 18, 2025, according to Sanofi and Regeneron.

A decision on ending use of oral phenylephrine as a nasal decongestant in OTC products will be made following public comment on FDA's proposed order.

ACAAI 2024. Two studies here showed that anaphylaxis protocols for EMS are outdated in many states and that many patients don't know how to use epinephrine.

The company is advancing development of the intranasal epinephrine medication following positive phase 1 data.

A summary of new data presented at the 2024 American College of Allergy, Asthma & Immunology Annual Scientific Meeting.

Updated mRNA COVID-19 vaccines, the first orally disintegrating tablet approved for pregnancy prevention, and 5 more.

The needle-free nasal spray, if approved, would be the first new administration method for epinephrine in young children in 35 years.

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The approval of neffy (epinephrine nasal spray) could help individuals and caregivers act sooner and feel safer treating a type 1 allergic reaction.

neffy (epinephrine nasal spray) is the first alternative to epinephrine administered by autoinjector or syringe and is comparable in efficacy to the gold standard.

PK data from a self-administration study are comparable to those seen following administration by a clinician and Tmax equal at 15 minutes.

Positive findings from a repeat dosing study of neffy under nasal allergen challenge conditions will support a potential PDUFA date of October 2, 2024, the company said.

Now FDA approved, Optinose’s Xhance is the first nonsurgical option for chronic rhinosinusitis both with and without nasal polyps.

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