Shots:

• The US FDA approved neffy 2mg for type I allergic reactions (anaphylaxis) in adults & children [≥30kg (66lbs)], with availability within 8wks. sNDA for children (15 to <30kg) to the US FDA is expected in Q3’24, with introduction in the EU during Q4’24 post EC’s decision
• Approval was based on 5 registration trials that met all EPs, with PK/PD data comparable to approved epinephrine injections. Studies included single & double doses in healthy adults, type I allergic patients, pediatrics (≥30kg) & those with allergic rhinitis
• neffy will be available for $25 to commercially insured patients via a co-pay savings program, $199 to those without insurance via BlinkRx & GoodRx & at no cost to uninsured eligible US residents via the ARS Pharma PAP; neffyconnect support program offers insurance navigation, financial assistance & educational resources