Alk-Abelló A/S
🇩🇰Denmark
ALK and ARS Pharma Partner to Co-Promote Neffy, First Needle-Free Epinephrine Nasal Spray for Anaphylaxis
• ALK and ARS Pharmaceuticals have entered a four-year co-promotion agreement for Neffy, the only FDA-approved needle-free epinephrine nasal spray for treating anaphylaxis, targeting 9,000 US pediatricians.
• ALK will deploy a dedicated 60-person pediatric sales force, with ARS Pharma covering most direct costs and offering performance-based revenue sharing when sales exceed certain market share thresholds.
• The partnership aims to address significant unmet needs in anaphylaxis treatment, as studies show only half of the 20 million Americans diagnosed with severe allergic reactions maintain active epinephrine prescriptions.
FDA Expands ODACTRA® Approval for House Dust Mite Allergy Treatment to Include Young Children
• The FDA has approved ODACTRA®, an under-the-tongue immunotherapy tablet, for treating house dust mite allergies in children aged 5-11 years, expanding its previous indication for ages 12-65.
• The approval is based on the largest pediatric allergy immunotherapy Phase 3 trial to date, involving 1,460 children across North America and Europe, demonstrating both efficacy and safety.
• This expansion addresses a significant medical need, as over ten million children aged 5-11 globally suffer from uncontrolled respiratory allergies, with house dust mites being a common trigger.
NICE Approves Novel Sublingual Tablet for Severe Dust Mite Allergy Treatment on NHS
• NICE has approved 12 SQ-HDM SLIT (Acarizax), the first-of-its-kind tablet treatment for severe dust mite allergic rhinitis, potentially benefiting 13,000 patients in England.
• The innovative therapy works by building immunity to house dust mites through daily administration over three years, offering hope for patients whose symptoms resist conventional treatments like steroid nasal sprays.
• Clinical experts highlight the treatment's life-changing potential for patients suffering from debilitating symptoms, including significant fatigue, congestion, and facial swelling.
ALK's Peanut Allergy Tablet Shows Positive Results, Advances to Phase II
• ALK's sublingual immunotherapy (SLIT) tablet for peanut allergy demonstrated safety and tolerability across multiple doses in a Phase I/II trial.
• Based on Phase I/II results, the peanut tablet development is advancing to Phase II to evaluate dose finding and efficacy.
• The Phase II trial, involving approximately 125 patients in the USA and Canada, is expected to be completed in 2026, with first patients dosed imminently.
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