Trial Profile
A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 05 Nov 2021
Price :
$35
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At a glance
- Drugs Infliximab (Primary)
- Indications Rheumatoid arthritis
- Focus Registrational; Therapeutic Use
- Sponsors Amgen
- 06 Dec 2019 According to an Amgen media release, the U.S. FDA has approved AVSOLA (infliximab-axxq) for all approved indications of the reference product, Remicade (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn's Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis in the adult and pediatric population, chronic severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.
- 15 Jun 2019 Results evaluating efficacy and safety of ABP 710 presented at the 20th Annual Congress of the European League Against Rheumatism
- 17 Dec 2018 According to an Amgen media release, the company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to REMICADE (infliximab). Data from the trial supported the submission.