Allergy

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 Two studies here showed that anaphylaxis protocols for EMS are outdated in many states and that many patients don't know how to use epinephrine.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

Your daily dose of the clinical news you may have missed.

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.

Your daily dose of the clinical news you may have missed.

Dr Ebisawa details the findings he recently presented at the 2024 AAAAI annual meeting, including adverse events and next steps for the study.

AAAAI 2024. Needle phobia is just one of the barriers to not just using an epinephrine autoinjector but to carrying one at all, according to 2 sets of surveys findings.

AAAAI 2024. In patients with treatment-resistant chronic spontaneous urticaria, neffy 1 mg and 2 mg resulted in improvement in itch, hives, urticaria, and erythema scores 5 minutes after dosing.

neffy (epinephrine nasal spray) delivered a PK and PD profile greater than or similar to that of IM epinephrine after extreme nasal challenge, reports ARS Pharmaceuticals.

AAAAI 2024. Dupilumab-treated eosinophilic esophagitis in children was also more often associated with comorbid asthma, according to researchers.

AAAAI 2024. New data on neffy (epinephrine nasal spray) include the first report of efficacy after oral food challenge in a pediatric population at risk for anaphylaxis.

AAAAI 2024. Reduction of AD signs and symptoms was significant among approximately half of study participants at 4 weeks and continuously rose through week 260, investigators report.

AAAAI 2024. Oral mucosal immunotherapy delivered via metered-dose toothpaste produced a statistically significant increase in IgG4 and a decrease in IgE/IgG4 ratio.

AAAAI 2024. The effects, seen 18 to 20 weeks after discontinuation of tezepelumab, suggest a persistent effect of thymic stromal lymphopoietin (TSLP) blockade in CSU.

The OUtMATCH trial showed that individuals as young as age 1 year could tolerate small amounts of peanut and other allergens without an allergic reaction.

Budesonide oral suspension is the first oral therapy for EoE and represents a needed option in the category, offering flexibility for both patients and clinicians.

AAAAI 2023. The TSLP inhibitor was superior to placebo in 2 post hoc analyses of the PATHWAY and NAVIGATOR clinical trials.

IDWeek 2022: New data show a greater than 60% reduction in acute exacerbations and need for antibiotics in patients with CS who used fluticasone propionate nasal spray.

For patients with chronic sinusitis, disease exacerbations often require use of antibiotics and steroids, in addition to medical office visits, all of which impact quality of life.

Dupilumab is approved for the treatment of eosinophilic esophagitis in patients aged ≥12 years weighing at least 40 kgs.