Trial Profile
Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 25 Oct 2021
Price :
$35
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At a glance
- Drugs Abicipar pegol (Primary) ; Ranibizumab
- Indications Wet age-related macular degeneration
- Focus Registrational; Therapeutic Use
- Acronyms SEQUOIA
- Sponsors Allergan
- 30 Jul 2020 Results published in the ClinicalTrials.gov Trial Registry
- 20 Jul 2020 According to a Molecular Partners AG media release, the company has been informed by the Allergan their intent to withdraw application filings with the European Medicines Agency (EMA). The AbbVie is committed to working with the regulatory agencies to determine the appropriate next steps and discuss requirements for potential resubmissions, following the recent decision from the U.S. Food and Drug Administration (FDA).
- 25 Jun 2020 According to an Allergan media release, the letter from the FDA indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of neovascular (wet) age-related macular degeneration (AMD). AbbVie plans to meet with the FDA to discuss their comments and determine next steps.