ARS Pharmaceuticals, Inc. announced that it has submitted its Day 180 response to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its Marketing Authorization Application (MAA) for neffy (epinephrine nasal spray), an investigational new drug to be indicated for the treatment of Type I allergic reactions including anaphylaxis. The submission follows receipt of Day 180 comments in the fourth quarter of 2023 that requested completion of a repeat dose study of neffy under nasal allergen challenge (NAC) conditions, and completion of updated nitrosamine testing. In February 2024, ARS Pharma announced the completion of its clinical study assessing repeat doses of neffy in patients with seasonal allergic rhinitis under nasal allergen challenge conditions.

ARS Pharma also completed its nitrosamine testing, per the FDA's draft guidance issued in August 2023, with no measurable levels of nitrosamines detected. Based on the timetable included in the Day 180 comments, ARS Pharma expects CHMP to issue its opinion on the neffy MAA in the second quarter of 2024. In parallel, ARS Pharma executed an exclusive license and distribution agreement for Australia and New Zealand with CSL Seqirus, a subsidiary of CSL Limited.

CSL Seqirus will apply for regulatory and pricing and reimbursement approvals, and will be responsible for commercializing neffy across Australia and New Zealand. ARS Pharma will receive an upfront payment and be eligible for event-driven milestone payments.