Trial Profile
A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira in Patients With Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 10 Mar 2024
Price :
$35
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At a glance
- Drugs Adalimumab (Primary)
- Indications Plaque psoriasis
- Focus Registrational; Therapeutic Use
- Acronyms ALVOPAD PS
- Sponsors Alvotech
- 23 Feb 2024 According to an Alvotech media release, the company announced that based on clinical data from AVT02-GL-101, AVT02-GL-301, and AVT02-GL-302 studies, the U.S. Food and Drug Administration (FDA) has approved SIMLANDI (adalimumab-ryvk) injection for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn's disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis.
- 24 Jul 2023 According to an Alvotech media release, the company announced that Teva and Alvvotech have agreed to expand their existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be issued by Alvotech.The partners continue working closely on matters concerning pending approval in the U.S. for AVT02.
- 13 Apr 2023 According to an Alvotech media release, the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to its partner Alvotech (NASDAQ: ALVO) for the Biologics License Application (BLA) for AVT02. The CRL stated that the application could not be approved at this time based on deficiencies associated with Alvotech's manufacturing facility that must be satisfactorily resolved. Additional review of the details following the recent FDA's re-inspection and CRL are being ass