March 28th 2025
Your daily dose of the clinical news you may have missed.
March 26th 2025
A 5-year study conducted in Germany showed only 7% of adults and 8% of children with severe anaphylaxis received epinephrine.
March 24th 2025
March 18th 2025
Among pediatric patients aged 1 month to 18 years with emergent anaphylaxis, cephalosporins were the leading antibiotics and ibuprofen the top NSAID implicated in a new study.
March 17th 2025
Community Practice Connections™: Navigating a New Era of Food Allergy Management
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Dupilumab Cuts Food Allergy IgE Levels in Small Study: Daily Dose
FDA Approves Neffy 1 mg Epinephrine Nasal Spray: Daily Dose
FDA Approves Omlyclo as First Interchangeable Omalizumab Biosimilar
Omlyclo is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria.
FDA Approves Neffy 1 mg Epinephrine Nasal Spray, Only Needle-Free Treatment for Patients Weighing Less Than 30 kg
The FDA approval of neffy 1 mg follows the earlier approval of the 5 mg version in August 2024.
Depemokimab Shows Significant Improvements in Rhinosinusitis with Nasal Polyps: New Research
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.
Dupilumab Shows Efficacy in Eosinophilic Esophagitis Regardless of Food Elimination Diets
The impact of food elimination diets on medication previously was unknown, according to new research presented at AAAAI 2025.
Omalizumab Efficacy and Safety Shown Superior to OIT in First Head-to-Head Multi-Food Allergy Trial
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.
Epinephrine Nasal Spray Shows Rapid Symptom Relief in Pediatric Anaphylaxis Study
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.
Dupilumab Reduces Specific IgE to Foods at 12 and 24 Months in Small Study
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.
Home-Based Therapy Achieves 100% Success Rate in Children with High-Threshold Peanut Allergy
AAAAI 2025: Phase 2 study results showed POIT with home-measured peanut products was not only highly effective but also posed few risks.
New neffy (epinephrine nasal spray) Data To Be Shared in 9 Presentations at 2025 AAAAI
Data on the epinephrine nasal spray will include findings from an efficacy study comparing anaphylaxis symptoms during oral food challenge, according to ARS.
AAAAI 2025: Omalizumab Shows Favorable Outcomes Versus Oral Immunotherapy in Multi‐Food Allergy Treatment
In a randomized clinical trial, omalizumab achieved a 36% treatment success rate for multi-food allergy compared with 19% for oral immunotherapy.
Transdermal Peanut Patch Shows Increased Clinical Benefit Over 5-Year Study
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.
Minimally Invasive Esophageal String Test Used to Monitor Eosinophilic Esophagitis in Children
Researchers at Phoenix Children’s Hospital conducted one of the largest real-world clinical evaluations of the esophageal string test in children.
ACG Updates Guidelines for Eosinophilic Esophagitis: Daily Dose
Neffy Update: FDA to Review 1 mg Version in First Quarter 2025, for Young Children with Type 1 Allergic Reactions
If approved, neffy 1 mg will be the only needle-free epinephrine treatment available for the younger, school-aged population.
Orexo Announces Positive Topline Data for Nasal Epinephrine Powder OX640 in People with Allergic Rhinitis
Treatments with the investigational rescue medication achieved clinically effective epinephrine levels faster than intramuscular injection.
American College of Gastroenterology Releases Updated Guidelines for Eosinophilic Esophagitis
The updated guidelines include 19 recommendations related to the diagnosis and management of eosinophilic esophagitis.
NDA Submission for Anaphylm (Epinephrine) Sublingual Film on Track for Q1 2025, Company Says
Aquestive Therapeutics announced positive feedback from the FDA this week that keeps NDA planning for the novel epinephrine product on solid ground.
FDA Accepts Dupilumab sBLA for Review for Treatment of Chronic Spontaneous Urticaria
The target action date for the FDA decision is April 18, 2025, according to Sanofi and Regeneron.
FDA May End Use of Oral Phenylephrine as Nasal Decongestant Ingredient in OTC Products
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.
Knowledge Gaps in How to Manage Anaphylaxis, Epinephrine Use, Persist for Patients, Even EMS
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.
Orexo Launches New OX640 Clinical Trial in People with Allergic Rhinitis
The company is advancing development of the intranasal epinephrine medication following positive phase 1 data.
New Data on Needle Free Epinephrine Spray Presented at ACAAI 2024
A summary of new data presented at the 2024 American College of Allergy, Asthma & Immunology Annual Scientific Meeting.
7 Drugs Approved for Primary Care: Q3 2024
Updated mRNA COVID-19 vaccines, the first orally disintegrating tablet approved for pregnancy prevention, and 5 more.
sNDA Goes to FDA for neffy 1 mg for Young Children with Type 1 Allergic Reactions
The needle-free nasal spray, if approved, would be the first new administration method for epinephrine in young children in 35 years.
FDA Approves Neffy as First Nasal Spray for Allergic Reactions: Daily Dose
Neffy, First Needle-Free Epinephrine, Fills a Deep Need for Patients, says Allergy Expert
The approval of neffy (epinephrine nasal spray) could help individuals and caregivers act sooner and feel safer treating a type 1 allergic reaction.
FDA Approves First Intranasal Epinephrine for Emergency Treatment of Allergic Reactions
neffy (epinephrine nasal spray) is the first alternative to epinephrine administered by autoinjector or syringe and is comparable in efficacy to the gold standard.
Topline PK Data Released on Self-Administered Epinephrine Sublingual Film for Severe Allergy
PK data from a self-administration study are comparable to those seen following administration by a clinician and Tmax equal at 15 minutes.