What Is ADAKVEO?

What to expect with ADAKVEO

ADAKVEO is a prescription medicine used in people 16 years of age and older who have sickle cell disease to help reduce how often painful crises happen. It is not known if ADAKVEO is safe and effective in children under 16 years of age.

ADAKVEO reduced the rate of pain crises^‡ by nearly half

45% vs placebo (based on a median annual rate of 1.63 pain crises with ADAKVEO vs 2.98 with placebo) in a 1-year study*

67 people taking ADAKVEO experienced a median annual rate of 1.63 pain crises^‡ compared with 65 people taking placebo who experienced 2.98 pain crises—a 45% reduction. The median is the number that is exactly in the middle of all results seen in the 1-year study.

PEOPLE TREATED WITH ADAKVEO SPENT FEWER DAYS IN THE HOSPITAL (VS PLACEBO)

• In a 1-year study,* 67 people taking ADAKVEO experienced a median annual rate of 4.0 days spent in the hospital vs 6.87 days for 65 people taking placebo—a 42% reduction. The median is the number that is exactly in the middle of all results seen in the 1-year study.
• The annual number of days a person was hospitalized included those days related to pain crises

How was ADAKVEO studied?

The safety and effectiveness of ADAKVEO were studied in 198 people with sickle cell disease.

67 people received ADAKVEO, and 65 people received placebo at study centers primarily across the United States.

In the 1-year study, pain crises were defined as painful episodes that led to a health care visit (ER, clinic, hospital, or local physician visit). Your doctor or health care provider may refer to pain crises as "vaso-occlusive crises" [vey-soh uh-kloo-siv] or VOCs. The following health conditions were also considered pain crises if they led to a health care visit:

• Respiratory issues, or acute chest syndrome
• Reduced blood flow or cell trapping in the liver, or heptic sequestration
• Reduced blood flow or cell trapping in the liver, or splenic sequestration
• Prolonged erections, or priapism

*In the 1-year SUSTAIN study, the safety and effectiveness of ADAKVEO were studied in 198 people with sickle cell disease who were 16 to 63 years old. 67 people received ADAKVEO and 65 people received placebo at study centers primarily across the United States.

^‡Pain crises were defined as painful episodes leading to a health care visit (ER, clinic, hospital, or local physician visit). Results were based on 132 patients with sickle cell disease who participated in a 1-year clinical study.

Who received ADAKVEO in the study?

The clinical study of ADAKVEO included people:

Across all genotypes of sickle cell disease, including HbSS, HbSC, HbSß⁰-thalassemia, HbSß⁺-thalassemia, and others

 

Who were of African, Hispanic, Caucasian, and other ancestries

 

Who had either 2-4 or 5-10 painful episodes (crises) in the last 12 months

Who were also on hydroxyurea, and people who were not