Allergy

 
ARS Pharma Submits Response to FDA Complete Response Letter for neffy (epinephrine nasal spray)
April 03, 2024

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.

Optinose Xhance approved by FDA as first medical therapy for CRS
March 15, 2024

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

Neffy May be Safe, Effective for Treatment of Urticaria Flares: Daily Dose
March 07, 2024

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

Phase 3 Findings on Neffy for Pediatric Patients with Severe Allergies: A Conversation with Motohiro Ebisawa, MD, PhD
March 04, 2024

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

Needle-free Epinephrine Delivery: Perceptions of Physicians, Patients, and Caregivers
February 27, 2024

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.

New Data Suggest neffy May be Safe, Effective for Treatment of Urticaria Flares
February 26, 2024

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 Generates Favorable PK/PD Data Under Nasal Allergen Challenge in Repeat Dosing Study Requested by FDA
February 26, 2024

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.

EoE in Children Treated with Dupilumab More Severe at Diagnosis, Study Finds
February 23, 2024

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

New neffy Data on Clinical Efficacy Presented at 2024 AAAAI Annual Meeting
February 22, 2024

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.

Dupilumab Effective Up to 5 Years in Adults with Moderate-to-Severe Atopic Dermatitis in Open-Label Extension Study
February 21, 2024

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.