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  5. Drug Trials Snapshots: OMVOH
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Drug Trials Snapshots: OMVOH

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic 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 healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the WINREVAIR Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

OMVOH (mirikizumab-mrkz)
ahm-VOH
Eli Lilly and Company
Approval date: October 26, 2023


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

OMVOH is an antibody that prevents signaling of the human IL-23 cytokine used to treat adults with moderately to severely active ulcerative colitis (UC).

How is this drug used?

OMVOH is an infusion that is administered in a healthcare facility by a healthcare provider directly into the vein (intravenous [IV] infusion) over 30 minutes every four weeks for the first three doses (Weeks 0, 4, and 8). After the first three doses of IV infusions, OMVOH is administered as an injection under the skin (subcutaneous [SC] injection) starting at Week 12, and every four weeks thereafter.

The healthcare provider will decide how many treatment cycles will be given.

Who participated in the clinical trials?

The FDA approved OMVOH based on evidence from two clinical trials of 1,062 patients with moderately to severely active UC. The trials were conducted at 383 sites from 35 countries in Eastern Europe (Czech Republic, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia), Western Europe (Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom), Asia (China, India, Japan, South Korea, Malaysia, Taiwan), North America (Canada, United States of America), Central and South America (Argentina, Mexico), and rest of the world (Australia, Israel, Russian Federation, Serbia, Turkey, Ukraine).

Approximately 13% (135) of the patients were from the United States. In addition, 36% (385) were from Europe, 24% (253) were from Asia, 16% (165) were from North America that included patients from the United States and Canada, 2% (18) were from Central and South America, and 23% (241) were from the rest of the world.

How were the trials designed?

The safety and efficacy of OMVOH were evaluated in two randomized, double-blind, placebo-controlled clinical trials that enrolled patients with moderately to severely active UC.

The first study (UC-1) was 12 weeks in duration and the primary endpoint was clinical remission at Week 12. UC-1 compared OMVOH 300 mg IV every four weeks for 12 weeks to placebo. Patients who responded to OMVOH during UC-1 were subsequently enrolled in a second study (UC-2) that was 40 weeks in duration. UC-2 compared OMVOH 200 mg SC every four weeks to placebo, and the primary endpoint was clinical remission at Week 40 (a total of 52 weeks of treatment).

DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes the percentage of male and female patients enrolled in the clinical trials that evaluated the efficacy of OMVOH.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 635 (60%) male patients and 427 (40%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes the percentage of patients by race in the clinical trials that evaluated the efficacy of OMVOH.

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, American Indian or Alaska Native, and other patients were in the clinical trial. In total, 757 (71%) White patients, 11 (1%) Black or African American patients, 269 (26%) Asian patients, 12 (1%) American Indian or Alaska Native patients, and 13 (1%) other patients participated in the clinical trial.

Source: Adapted from FDA Review
* Other: Race not reported (10 patients) or multiple races (3 patients)

Figure 3 summarizes the percentage of patients by age enrolled in the clinical trials that evaluated the efficacy of OMVOH.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 981 (92%) patients younger than 65 years of age and 81 (8%) patients 65 years of age or older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes the percentage of patients by ethnicity in the clinical trials that evaluated the efficacy of OMVOH.

Figure 4. Baseline Demographics by Ethnicity

Pie chart summarizing how many Hispanic, not Hispanic, and not reported patients were in the clinical trial. In total, 35 (3%) Hispanic or Latino patients, 786 (74%) not Hispanic or Latino patients, and 241 (23%) not reported patients participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

OMVOH was better than placebo at helping to get UC under control (induce clinical remission) and keep UC under control (maintain clinical remission). It may help reduce or stop the need to take corticosteroid medicines. It also may help improve the way the lining of the large intestine looks to a healthcare provider during a colonoscopy procedure.

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

  • Sex: OMVOH was similarly effective in males and females.
  • Race: OMVOH worked similarly in White and Asian patients. The number of patients of races other than White and Asian was limited; therefore, differences in response among other races could not be determined.
  • Age: There was an insufficient number of patients older than 65 years of age to determine whether OMVOH worked differently in older adults.

What are the possible side effects?

OMVOH may cause serious allergic reactions that may need to be treated in a hospital and may be life-threatening. OMVOH may also increase the risk of serious infections and liver injury.

The most common side effects in patients treated with OMVOH include upper respiratory infections, joint pain, rash, injection site reaction, headache, and herpes viral infections.

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

  • Sex: The occurrence of side effects was similar in males and females.
  • Race: The occurrence of side effects was similar in White and Asian patients. The number of patients of races other than White and Asian was limited; therefore, differences in side effects other races could not be determined.
  • Age: The number of patients older than 65 was insufficient to determine any differences in side effects in adults older than 65.

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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