A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age
Latest Information Update: 15 Apr 2025
At a glance
- Drugs Fremanezumab (Primary)
- Indications Headache; Migraine
- Focus Therapeutic Use
- Acronyms SPACE
- Sponsors Teva Branded Pharmaceutical Products R&D
- 07 Apr 2025 According to a Teva Pharmaceutical Industries media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for AJOVY (fremanezumab-vfrm) to expand the indication to include the prevention of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. The application was based on positive results from the Phase 3 SPACE trial.
- 04 Dec 2024 Primary endpoint has been met (Mean change in the monthly average number of migraine days after the first dose of study drug) , according to Teva Pharmaceutical Industries media release
- 04 Dec 2024 According to a Teva Pharmaceutical Industries media release, full data from this trial presented as a late breaker at European Headache Congress (EHC) 4-7 December in Rotterdam, Netherlands