(Reuters) -The U.S. Food and Drug Administration (FDA) has declined to approve ARS Pharmaceuticals’ nasal spray for allergic reactions and requested completion of a repeat-dose study to support a potential approval, the company said on Tuesday.
ARS Pharma was seeking approval for the nasal spray treatment, Neffy, as an emergency treatment of allergic reactions including anaphylaxis, in adults and children who weigh more than 30 kg.
“We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote,” CEO Richard Lowenthal said.
ARS Pharma said it anticipates a resubmission in the first half of 2024 an FDA action date in the second half, adding that it plans to appeal the issuance of the FDA’s Complete Response Letter.
Patients have to be dependant on EpiPen and other autoinjectors like Sanofi Auvi-Q filled with epinephrine, a life-saving drug used by people at risk of experiencing anaphylaxis.
Anaphylaxis is a life-threatening allergic reaction that can occur within seconds of being exposed to an allergen and can be fatal if untreated.
The company’s application was based on trials in healthy patients and in those having a rhinitis attack. The nasal spray showed a comparable response to injectable products in delivering epinephrine.
Studies did not test the treatment in people with anaphylaxis due to ethical concerns, but rival Viatris in June petitioned the FDA to require that ARS conduct more trials that closely mimic real-world conditions.
The biggest concern with the drug is that it has not been studied in a real-world setting with people who have suffered anaphylaxis due to ethical purposes, said James Tarbox, an allergist at Texas Tech University Health Sciences Center.
(Reporting by Christy Santhosh and Sriparna Roy in Bengaluru, additional reporting by Jahnavi Nidumolu; Editing by Maju Samuel, Dhanya Ann Thoppil and Varun H K)
