Key takeaways:
- The recommendation was based on data from more than 700 study participants.
- European Commission authorization is expected in the third quarter.
- The FDA has an action date of Oct. 2.
An epinephrine nasal spray is closer to approval in Europe, according to a press release from ARS Pharmaceuticals.
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on ARS Pharmaceuticals’ application for marketing authorization for its EURneffy epinephrine nasal spray. CHMP also recommended related market authorization in the European Union for EURneffy’s use in emergency care.
“Today’s announcement marks a major milestone in the treatment of severe allergies and moves us one step closer to bringing EURneffy to patients in the EU as the first and only needle-free adrenaline option for the emergency treatment of allergic reactions, up to anaphylaxis,” Richard Lowenthal, cofounder, president and CEO of ARS Pharmaceuticals, said in the press release.
Richard Lowenthal
“EURneffy’s needle-free, smaller form and longer and less temperature-sensitive shelf life may increase the likelihood that patients will both carry and administer adrenaline, which improves outcome of allergic reactions,” Lowenthal said.
CHMP based its decision on data from studies involving more than 700 participants and more than 1,200 administrations of the nasal spray examining efficacy based on surrogate pharmacodynamic endpoints, ARS Pharmaceuticals said, calling its work “one of the most extensive nasal spray development programs in history.”
Researchers studied the pharmacodynamics as well as the pharmacokinetics of 2 mg doses of EURneffy across a range of conditions, the company continued, such as single and repeat dosing, self-administration, pediatrics, nasal allergen challenges and infectious rhinitis caused by colds or flus.
ARS Pharmaceuticals expects marketing authorization from the European Commission in the third quarter of 2024, with full European availability in the fourth quarter via a pharmaceutical company with an established commercial footprint in Europe.
CHMP’s positive opinion for this needle-free method for epinephrine delivery a was a “huge win for the food allergy community,” Sung Poblete, PhD, RN, CEO of Food Allergy Research & Education (FARE), said in a press release from the nonprofit.
“The more than 33 million people in the U.S. with the disease of food allergy are anxious to have the same choices for epinephrine delivery,” Poblete said.
In the United States, ARS Pharmaceuticals submitted a response letter to the FDA in April for its neffy brand of the nasal spray after the Administration requested additional research. The FDA has given neffy an Oct. 2 Prescription Drug User Fee Act action date.
“We celebrate this win for the food allergy community in the EU and we hope to be able to celebrate neffy’s availability in the U.S. very soon, because patients can’t wait for this life-saving treatment option,” Poblete continued.
ARS Pharmaceuticals’ mixed application will benefit from an 8-year period of data protection, the company said, preventing other applicants from relying on support from this application.
EURneffy also will benefit from a 10-year period of marketing protection that will prevent generic, hybrid or biosimilar versions from entering the market, ARS Pharmaceuticals added, noting a 2039 expiration date for its matter and method of treatment patents.