According to ARS Pharmaceuticals, the EMA has accepted the company’s marketing authorization application for its Neffy (ARS-1) epinephrine nasal spray for the emergency treatment of anaphylaxis. ARS recently announced that Recordati had acquired marketing rights to ARS-1 in the EU, Iceland, Liechtenstein, Norway, Switzerland, the UK, Russia/CIS, Turkey, the Middle East, and francophone Africa, a total of 93 countries.
In February 2019, the FDA granted Fast Track designation to ARS-1. Earlier this year, ARS published results from three Phase 1 studies, EPI 03, EPI 04, and EPI 07, which all demonstrated equivalent exposure for ARS-1 compared to injected epinephrine.
ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “This first of our anticipated global regulatory submissions is an important milestone for Neffy and for the millions of people in Europe living with life-threatening allergies. We look forward to working together with the EMA and our marketing partner Recordati to make this simple to use, rapidly administered and needle-free way to treat severe allergic reactions available for patients and help reduce the risks of anaphylaxis.”
Read the ARS Pharmaceuticals press release.
