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  5. Drug Trials Snapshots: CRESEMBA (aspergillosis)
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Drug Trials Snapshots: CRESEMBA (aspergillosis)

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 CRESEMBA Prescribing Information for complete information.

CRESEMBA (isavuconazonium sulfate)
(Crē-SEM-bah)
Astellas Pharma US, Inc.
Approval date:  March 6, 2015


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

CRESEMBA is a drug that is used to treat adults with a rare but serious fungal infection called invasive aspergillosis. This infection occurs most often in people with weak immune systems.

CRESEMBA is also used for the treatment of adults with a rare but serious fungal infection called invasive mucormycosis. This is discussed in a separate Snapshot.

How is this drug used?

CRESEMBA is administered by a health care professional directly into the bloodstream through a needle in the vein. This is known as an intravenous, or IV, infusion. CRESEMBA is also available as a capsule to be taken by mouth.

What are the benefits of this drug?

The trial showed that CRESEMBA was as safe and effective in treating invasive aspergillosis as voriconazole, another drug used to treat fungal infections.  

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

Subgroup analyses were conducted for sex, race and age.

  • Sex: CRESEMBA was similarly effective in men and women.
  • Race: The number of non-White, non-Asian patients was limited. CRESEMBA appeared to be less effective in Asians compared to Whites. However, this difference was seen in a single center in South Korea and not in all Asian patients.
  • Age: CRESEMBA was similarly effective in patients below 65 years of age and those 65 years of age and above.

What are the possible side effects?

The most common side effects are nausea, vomiting, diarrhea, headache, abnormal liver blood tests, low potassium levels in the blood, constipation, shortness of breath, cough, and swelling of the arms and legs.

CRESEMBA may also cause serious side effects, including liver problems, infusion reactions, and severe allergic and skin reactions.

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

Subgroup analyses were conducted for sex, race and age.

  • Sex: The risk of overall side effects was similar in men and women.
  • Race: The number of non-White, non-Asian patients was limited. The risk of overall of side effects was similar in Whites and Asians.
  • Age: The risk of overall side effects was similar in patients 65 years and below and those above 65 years. Certain side effects—called serious adverse events1—were seen more frequently in patients above 65 years.

1 Serious adverse event was defined as any event that resulted in one of the following: death, life-threatening event, required hospitalization or extended a current hospital stay, persistent or significant disability/incapacity, or congenital anomaly or birth defect.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved CRESEMBA based on evidence from a clinical trial of 516 patients believed or confirmed to have invasive aspergillosis. The trial was conducted at 102 centers in 12 countries, including those in North America, South America, Europe, Asia, and Africa.

Figure 1 summarizes how many men and women were enrolled in the clinical trial.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were enrolled in the CRESEMBA clinical trial.  In total, 308 men (60%) and 208 women (40%) participated in the clinical trial.

Source: From Clinical Reviewer

Figure 2 summarizes how many patients by race were in the clinical trial.

Figure 2. Baseline Demographics by Race

Bar chart summarizing the percentage of patients by race enrolled in the CRESEMBA clinical trial. In total, 402 White (78%), 2 Black (0.4%), 109 Asian (21%), 2 identified as Other (0.4%), and 1 patient where data was missing (0.2%) participated in the clinical trial.

Source: From Clinical Reviewer

Table 1. Baseline Demographics by Race

Race Number of Patients Percentage (%)
White 402 78
Black or African American 2 0.4
Asian 109 21
Other 2 0.4
Missing 1 0.2

Source: From Clinical Reviewer

The figure below summarizes the ages of patients in the clinical trial.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many individuals of certain age groups were enrolled in the CRESEMBA clinical trial.  In total, 391 were between 17 and 64 years (76%), 101 were between 65 and 74 years (19%), and 24 were over the age of 75 (5%).

Source: From Clinical Reviewer

How were the trials designed?

CRESEMBA was approved by the FDA based on a trial of 516 patients. Patients were randomly assigned to treatment with either CRESEMBA or voriconazole. Neither the patients nor the health care professionals knew which patients received CRESEMBA and which patients received voriconazole. The trial was designed to evaluate whether CRESEMBA works as well as voriconazole for the treatment of invasive aspergillosis.

 

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

MEDICAL REVIEW

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