ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine. The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company set an anticipated target action date of mid-2023 for its PDUFA (Prescription…
FDA advisory committee backs AstraZeneca’s albuterol/budesonide for asthma
FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16 to 1 in favor of the albuterol/budesonide (PT027) from AstraZeneca (Nasdaq:AZN) to treat asthma in people at least 18 years old. The voting proposition asked whether the data supported a favorable benefit-risk assessment for various age groups. The advisory committee did not endorse albuterol/budesonide for patients 12…
A closer look at the potential of Takeda’s Takhzyro in pediatric hereditary angioedema study
Takeda (NYSE:TAK) recently announced that in the open-label Phase 3 SPRING study, children aged 2 to 12 had 94.8% fewer hereditary angioedema (HAE) attacks when receiving Takhzyro (lanadelumab-flyo) over 52 weeks compared to baseline The primary objectives of the SPRING study was to evaluate the safety and pharmacokinetics of Takhzyro in HAE patients aged 2…
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Takeda (NYSE:TAK) has announced that in the open-label Phase 3 SPRING study, children aged 2 to 12 had 94.8% fewer hereditary angioedema (HAE) attacks during treatment with Takhzyro (lanadelumab-flyo) over 52 weeks compared to baseline. The Osaka, Japan–based company plans on presenting the data at the European Academy of Allergy and Clinical The SPRING study…
Intrommune extends scope of Phase 1 trial for peanut-allergy-treating toothpaste
The food-allergy-focused biotech Intrommune Therapeutics is announcing that it is extending the duration of the ongoing Phase 1 OMEGA clinical trial of INT301 in adults with peanut allergy. The alteration will lengthen the study duration to 48 weeks to include a maintenance period. The study duration was previously 26 weeks. The New York City–based company…