London – September 16, 2026 -- Hikma Pharmaceuticals PLC said regulators in the United States, Europe, and the UK have accepted for review its investigational epinephrine nasal spray, a needle-free treatment for anaphylaxis, with an additional filing lodged in Canada.
FDA accepts 505(b)(2) application for non-injectable anaphylaxis treatment
The US Food and Drug Administration has taken up a New Drug Application submitted under the 505(b)(2) pathway, which includes the required non-clinical and clinical data package supporting approval of the nasal spray for emergency anaphylaxis treatment.
European and UK regulators validate hybrid marketing authorisation dossier
In Europe, Hikma's hybrid marketing authorisation dossier has been validated and accepted through the Decentralised Procedure, targeting authorisation across multiple European markets. In the UK, the same dossier has entered review via the National Procedure, with Hikma seeking approval in that market as well.
Canadian filing signals broader international rollout plans
Hikma has also filed a submission in Canada and plans to extend regulatory filings to additional markets beyond the US, Europe, UK, and Canada in due course.
Company frames filing as milestone for complex product pipeline
Hafrun Fridriksdottir, President of Hikma US and Chief R&D Officer, said the regulatory acceptances mark an important growth milestone for Hikma's complex product line and would give patients and caregivers an alternate access route to life-saving anaphylaxis treatment, reflecting the company's focus on differentiated medicines and broadening affordable patient access.
Hikma cautioned that the epinephrine nasal spray remains investigational and has not been approved by the FDA, and that submission of an application does not guarantee approval or confirm the product's safety or efficacy. The company noted there is no assurance the product or any specific indication will ultimately receive regulatory clearance.