After a long-awaited series of research phases and trials, the FDA recently granted approval for Neffy as the ‘First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis.’
Speaking to In Vivo, Lowenthal summarized the current work undertaken by ARS Pharmaceuticals, Inc., looking at successes and challenges across Neffy’s development. Addressing the range of factors that led to this unmet area, he explained the current challenges posed by epinephrine auto-injectors.
Taking the EpiPen as a point of comparison, Lowenthal highlighted the efficacy and accessibility of Neffy, enhancing its potential to improve patient outcomes. Alongside discussions of current progress, he further raised points of action that ARS is hopeful to take across the next year.
From developing a lower-dose Neffy for children below 30kg, to seeking regulatory approval in the UK, Canada, China, Australia, New Zealand, and Japan – the upcoming timeline appears promising for this growing biotech.
Timestamps:
1:04 History And Development of ARS Pharma
2:50 Where has this unmet need come from?
12:30 Making Neffy suitable for children >15kg
14:30 Trial stages and approvals
18:12 Why switch to Neffy?
23:22 Recent FDA approval
29:34 Future of ARS pharma and upcoming goals
