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Drug Trials Snapshots: UPLIZNA

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the UPLIZNA Package Insert for complete information.

UPLIZNA (inebilizumab-cdon)
up liz' nah
Viela Bio, Inc.
Approval date: June 11, 2010


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

UPLIZNA is used to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients with a particular antibody (who are anti-aquaporin-4 or AQP4 antibody positive).

NMOSD is a rare disease that most commonly affects the optic nerves and spinal cord. It is characterized by relapses (attacks) that cause vision loss and serious disability which can lead to death.

How is this drug used?

UPLIZNA is given directly into the vein (intravenous infusion) over 90 minutes by a healthcare provider. First two infusions are given two weeks apart followed by one infusion every six months.

What are the benefits of this drug?

UPLIZNA reduces attacks of the disease.

The risk of an NMOSD relapse in the patients who were treated with UPLIZNA was reduced by 77% when compared to the placebo treatment group.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: The majority of patients in the clinical trial were women. Differences in response to UPLIZNA between men and women could not be determined.
  • Race: The majority of patients in the clinical trial were White. Differences in response to UPLIZNA among races could not be determined.
  • Age: The majority of patients in the clinical trial were younger than 65 years of age. Differences in response to UPLIZNA between patients below and above 65 years of age could not be determined.

What are the possible side effects?

UPLIZNA may cause serious side effects including infusion reactions, infections, and a harm to un unborn baby.

The most common side effects are urinary tract infection and joint pain.

Were there any differences in side effects among sex, race and age?

  • Sex: The majority patients in the clinical trial were women. Differences in side effects between men and women could not be determined.
  • Race: The majority patients in the clinical trial were White. Differences in side effects among races could not be determined.
  • Age: The majority of patients in the clinical trial were younger than 65 years of age. Differences in side effects between patients below and above 65 years of age could not be determined.

WHO WAS IN THE CLINICAL TRIALS?

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 summarizes how many men and women were in the clinical trial.

Figure 1. Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trial. In total, 200 women (94%) and 13 men (6%) participated in the clinical trial.

FDA Review

Figure 2 summarizes the percentage of patients by race in the clinical trial.

Figure 2. Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the clinical trial. In total, 110 White (52%), 19 Black or African American  (9%), 45 Asian (21%) , 16 American Indian or Alaska Native (7%) and 23 Other (11%)

FDA Review

Figure 3 summarizes the percentage of patients by age in the clinical trial.

Figure 3. Demographics by Age

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total,  203 (95%) were less than 65 and 10 patients were 65 years and older (5%).

FDA Review

Figure 4 summarizes the percentage of patients by ethnicity in the clinical trial.

Figure 4. Demographics by Ethnicity

Pie charts summarizing ethnicity of patients enrolled in the clinical trial. In total,  40 patients were Hispanic or Latino (19%) and 173 patients were not Hispanic or Latino (81%).

FDA Review

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 Study Day 197 evaluated by a blinded, independent, adjudication committee, who determined whether the attack met protocol-defined criteria.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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