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- Studies of uplizna fda approval
FDA Approves New Therapy for Rare Disease Affecting Optic …
WEBJune 11, 2020. The U.S. Food and Drug Administration today approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder...
- Estimated Reading Time: 4 mins
See results only from fda.govDrug Trials Snapshots: UPLI…
Approval date: June 11, 2020. DRUG TRIALS SNAPSHOT SUMMARY: What …
label - Food and Drug Admi…
Initial U.S. Approval: 2020 _____ INDICATIONS AND USAGE . UPLIZNA …
Drug Trials Snapshots: UPLIZNA | FDA
- Who participated in the clinical trials?
The FDA approved UPLIZNA based on evidence from one clinical trial (Trial 1/ NCT02200770) of 213 patients with NMOSD. The trial was conducted at 82 sites in 24 countries (including the Unites States) in North and South America, Europe, Africa, Asia and Australia. Figure 1 summar… - How were the trials designed?
The safety and efficacy of UPLIZNA were established in a randomized (3:1) double-blind, placebo-controlled trial that enrolled 213 patients with NMOSD who were anti-AQP4 antibody positive. The primary efficacy endpoint was the time to the onset of the first adjudicated relapse on or before …
- Estimated Reading Time: 5 mins
- Who participated in the clinical trials?
UPLIZNA® (inebilizumab-cdon) | NMOSD Treatment
WEBUPLIZNA is FDA approved for. adults with AQP4-antibody–positive NMOSD and provides the following benefits: ~90% of patients were attack free at 28 weeks. 2 doses a year* Safety profile similar to placebo. * …
- Generic Name: Inebilizumab-cdon
This medication is used to treat a certain nervous system disorder that affects the eye (optic) nerve and spinal cord (neuromyelitis optica spectrum disorder-NMOSD).
May Treat: Neuromyelitis optica with anti-aquaporin-4 antibodies
Drug Class: Immunosuppressive - CD19 (B Lymphocyte) Monoclonal Antibody
Availability: Prescription Required
Pregnancy: Consult your doctor. This medication may be harmful to an unborn child.
Lactation: Consult a doctor before using
Alcohol: Limit intake while taking this medication
Driving: May cause drowsiness or dizziness. Use caution
Manufacturer: HORIZON THERAPE
PrecautionsFor informational purposes only. Consult a medical professional for advice.
Source: First Databank Learn more
- People also ask
Viela Bio Announces U.S. FDA Approval of UPLIZNA™
WEBGAITHERSBURG, Md., June 11, 2020 (GLOBE NEWSWIRE) -- Viela Bio (Nasdaq: VIE) today announced that the U.S. Food and Drug Administration (FDA) has approved …
What Makes UPLIZNA® (inebilizumab-cdon) Different?
WEBFDA approval means that the FDA has determined that the medication is effective for its intended use. The benefits of the medication are greater than its risks when used as intended. Placebo group data (n=47) were …
FDA Approves New Therapy for Rare Disease Affecting Optic …
WEBSILVER SPRING, Md., June 11, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Uplizna (inebilizumab-cdon) injection for intravenous …
AstraZeneca spinout wins first FDA approval 2 years after launch
WEBJun 12, 2020 · Approved Thursday as Uplizna, Viela’s drug will launch later this month and compete with existing therapies from Roche and Alexion Pharmaceuticals. The condition …
New NMOSD drug approved by the FDA
WEBJun 18, 2020 · Inebilizumab (Uplizna) has been cleared for neuromyelitis optica spectrum disorder (NMOSD). The monotherapy drug is now the first and only B cell-depleting …
Viela Bio Announces U.S. FDA Approval of UPLIZNA™ - Duke OTC
WEBViela Bio (Nasdaq:VIE) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNATM (inebilizumab-cdon) for the treatment of adult …
Viela Bio Announces U.S. FDA Approval of UPLIZNA™ …
WEBJun 11, 2020 · Viela Bio (VIE) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNATM (inebilizumab-cdon) for the treatment …
Inebilizumab-cdon: USFDA Approved for the Treatment of …
WEBPMID: 34011260. DOI: 10.2174/1570163818666210519103001. Abstract. Inebilizumab-cdon (Uplizna™) was currently approved by the United States Food and Drug …
Uplizna (inebilizumab-cdon) FDA Approval History - Drugs.com
WEBUplizna FDA Approval History. Last updated by Judith Stewart, BPharm on Jan 27, 2021. FDA Approved: Yes (First approved June 11, 2020) Brand name: Uplizna. Generic …
WEBNow FDA approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Please see …
What Is NMOSD? | UPLIZNA® (inebilizumab-cdon)
WEBUPLIZNA is the only FDA-approved medicine for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD that targets B cells at nearly all stages of their lifecycle. This …
FDA approves Uplizna (inebilizumab-cdon) for NMOSD
WEBOn June 11, 2020, the U.S. Food and Drug Administration approved Uplizna (inebilizumab-cdon) for the treatment of neuromyelitis optica spectrum disorder …
Mechanism of Action | UPLIZNA® (inebilizumab-cdon) for HCPs
WEBUPLIZNA is the only FDA-approved therapy for NMOSD that eliminates the primary cellular sources of AQP4-IgG production, including plasmablasts and some plasma …
UPLIZNA® (inebilizumab-cdon) | Healthcare Professional Home
WEBUPLIZNA® (inebilizumab-cdon) is the first and only FDA-approved CD19+ B-celldepleting monotherapy proven to reduce attacks in adult AQP4-IgG+ NMOSD patients. See safety …
Inebilizumab - Wikipedia
WEBInebilizumab was approved for medical use in the United States in June 2020, [8] [10] in the European Union in April 2022, [7] and in Canada in December 2023. [1] . The U.S. …
Inebilizumab: First Approval - PMC - National Center for …
WEBJul 29, 2020 · Inebilizumab (Uplizna™; inebilizumab-cdon in the USA) is a humanised anti-CD19 monoclonal antibody being developed by Viela Bio for the treatment of a range of …
WEBInitial U.S. Approval: 2020 _____ INDICATIONS AND USAGE . UPLIZNA is a CD19-directed cytolytic antibody indicated for the treatment of neuromyelitis optica spectrum …
WEB• On June 11, 2020, the FDA announced the approval of Viela Bio’s Uplizna (inebilizumab-cdon), for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult …
Dosing and Prescribing Information | UPLIZNA® (inebilizumab …
WEB90 minutes each 1. Treatment comparison among UPLIZNA and other FDA-approved therapies for NMOSD 1-3. Access and Support. Learn about Horizon By Your Side, a …
Starting UPLIZNA® (inebilizumab-cdon)
WEBUPLIZNA is the only FDA-approved NMOSD therapy with treatment just two times a year, following two initial doses. Michelle: The draw to UPLIZNA was absolutely the once …
FDA Approves New Treatment for Uncomplicated Urinary Tract …
WEBApril 24, 2024. Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract …
FDA Approves Antibiotic to Treat Urinary Infections - The New …
WEBBy Andrew Jacobs. April 24, 2024. The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, …
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