CHMP Recommends Approval Of ARS Pharma's EURneffy For Emergency Treatment Of Allergic Reactions

(RTTNews) - ARS Pharmaceuticals, Inc. (SPRY) Friday said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for EURneffy (adrenaline nasal spray) for the emergency treatment of allergic reactions (anaphylaxis).

The formal marketing authorization of EURneffy, which is the trade name for neffy in the European Union, is expected in the third quarter of this year. The company expects to make the drug available in Europe in the fourth quarter.

The recommendation for marketing authorization is based on comprehensive data package comparing EURneffy to approved injectable products across a range of dosing scenarios as well as supportive historical data from injectable products.

The company's New Drug Application to the FDA for neffy is under review with a decision expected on October 2.