WHY OXBRYTA?

TULLY

High school senior, trumpet player, and actual Oxbryta patient

THE OXBRYTA CLINICAL TRIALS

Oxbryta Tablets and Oxbryta 300 mg Tablets for Oral Suspension were studied in 2 different age groups in 2 clinical trials: HOPE and HOPE-KIDS 1. The trials studied similar target goals and showed similar results.

Jump To:

THE HOPE TRIAL STUDIED PATIENTS AGES 12 AND UP

Oxbryta Tablets were studied in 90 patients who received Oxbryta (daily dose of 1500 mg) and 92 patients who received a placebo (sugar pill). The trial included patients ages 12 and up who took the medication daily for 24 weeks. Patients who were already taking hydroxyurea at the start of the clinical trial continued to do so for the entire time of the trial.

The main goal of the HOPE clinical trial was to determine if treatment with Oxbryta helped improve hemoglobin. Another goal was to determine if Oxbryta also helped improve hemolysis (the breakdown of red blood cells).

In this study, after 2 weeks on Oxbryta 1500 mg, some patients observed an increase in hemoglobin levels from where they started vs a decrease for those in the placebo group.

63 patients (70%) receiving Oxbryta 1500 mg completed the study through 72 weeks.

Oxbryta 500 mg Tablets clinical study graphic

OXBRYTA SIGNIFICANTLY INCREASED
HEMOGLOBIN LEVELS

Oxbryta 500 mg Tablets hemoglobin level increase

When hemoglobin levels increase, a greater number of red blood cells are able to help deliver oxygen throughout the body.


Oxbryta 500 mg Tablets clinical trial data

51% of all Oxbryta patients who enrolled in the trial saw a rise of more than 1 g/dL (vs 7% of the patients taking placebo).

Oxbryta 500 mg Tablets clinical trial data

42% of Oxbryta patients saw a rise of more than 1.5 g/dL (vs 3% of the patients taking placebo).

Oxbryta 500 mg Tablets clinical trial data

27% of Oxbryta patients saw a rise of more than 2 g/dL (vs 1% of the patients taking placebo).

Improvements in hemoglobin levels were observed in patients regardless of whether they were taking hydroxyurea.

OXBRYTA SIGNIFICANTLY DECREASED HEMOLYSIS
(the breakdown of red blood cells)

Oxbryta 500 mg Tablets hemolysis results graphic

When fewer red blood cells break down, it improves anemia. This can be measured in different ways, including bilirubin

Bilirubin [bil-uh-roo-bin] is a substance made in the body when red blood cells break down. Low bilirubin levels are good because that means fewer red blood cells are breaking down, which can lead to anemia.
levels and reticulocyte
A reticulocyte [ri-tik-uh-luh-site] is a new or “baby” red blood cell that has not yet fully developed. When your body isn’t getting enough oxygen, the body works hard to add more red blood cells by creating reticulocytes.
 count.

When fewer red blood cells break down, it improves anemia. This can be measured in different ways, including bilirubin levels and reticulocyte count.

Oxbryta 500 mg Tablets bilirubin levels graphic

On average, bilirubin levels fell by 29.1% for patients on Oxbryta vs 2.8% for the placebo group.

Oxbryta 500 mg Tablets reticulocyte count graphic

On average, reticulocyte counts fell by 18.0% for patients on Oxbryta vs an increase of 6.8% for the placebo group.

"I like to ride my bike and go places, so I make sure to eat well, drink lots of water, and let my body rest every day."

– ABRAHAM

Actual Oxbryta patient

ABRAHAM

Actual Oxbryta patient

THE HOPE-KIDS 1 TRIAL STUDIED PATIENTS AGES 4 TO LESS THAN 12

The HOPE-KIDS 1 trial is an open-label study to evaluate Oxbryta in pediatric patients with sickle cell. An open-label study, by definition, has no placebo arm.

The data represents the results from 45 patients as of September 30, 2020. This is an ongoing study and additional results will be provided at the study conclusion.

Oxbryta 300 mg Tablets for Oral Suspension was studied in 45 patients ages 4 to less than 12 who received Oxbryta 300 mg Tablets for Oral Suspension (daily dose based on body weight). The trial also included 11 patients ages 12 to < 17 who received Oxbryta (daily dose of 1500 mg). All patients took the medication daily for 24 weeks. Patients who were already taking hydroxyurea at the start of the clinical trial continued to do so for the entire time of the trial.

The HOPE-KIDS 1 clinical trial explored if Oxbryta helped improve hemoglobin and hemolysis (the breakdown of red blood cells).

Oxbryta 300 mg Tablets for Oral Suspension

45
patients

Oxbryta 300 mg Tablets for Oral Suspension study

OXBRYTA INCREASED HEMOGLOBIN

Oxbryta 300 mg Tablets for Oral Suspension study

36% of all Oxbryta patients who enrolled in the trial saw a rise of more than 1g/dL.

Oxbryta 300 mg Tablets for Oral Suspension bilirubin levels graphic

35% of Oxbryta patients saw a rise of more than 1.5 g/dL.

Oxbryta 300 mg Tablets for Oral Suspension reticulocyte count graphic

21% of Oxbryta patients saw a rise of more than 2 g/dL.

  • When hemoglobin levels increase, a greater number of red blood cells are able to help deliver oxygen throughout the body
  • Improvements in hemoglobin levels were observed in patients regardless of whether they were taking hydroxyurea

Oxbryta’s impact on hemolysis was also studied in the HOPE-KIDS 1 trial, but the evaluation was exploratory and cannot be used to support a conclusion.

Talk to your healthcare provider to see if Oxbryta could be right for you.

Patient Brochure Slim Jim

Oxbryta Patient Brochure

Learn more about sickle cell and treatment with Oxbryta, and find specific questions you can ask your healthcare provider to get the conversation started.

DOWNLOAD

"I like to draw and play on my tablet."

– HAJAR

Actual Oxbryta patient

HAJAR

Actual Oxbryta patient

Always talk to your healthcare provider about any side effects you may be experiencing.

SELECT OXBRYTA SAFETY INFORMATION

Do not take icon

Do not take Oxbryta if you or your child have had an allergic reaction to voxelotor or any of the ingredients in Oxbryta. See the end of the patient leaflet for a list of the ingredients in Oxbryta.

What should I avoid while taking Oxbryta?
Do not take St. John’s wort during treatment with Oxbryta.

Serious side effects icon

Oxbryta can cause serious side effects including serious allergic reactions.
Tell your doctor or get emergency medical help right away if you get:

  • rash
  • hives
  • shortness of breath (difficult breathing)
  • swelling of the face
Most common side effects icon

The most common side effects of Oxbryta include:

  • headache
  • diarrhea
  • stomach-area (abdominal) pain
  • nausea
  • rash or hives
  • fever

The most common side effects of Oxbryta in children ages 4 to less than 12 years of age include:

  • fever
  • vomiting
  • rash
  • stomach-area (abdominal) pain
  • diarrhea
  • headache

Oxbryta has been studied in people with sickle cell and was shown to be well tolerated.


These are not all the possible side effects of Oxbryta. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Global Blood Therapeutics, Inc. at 1-833-428-4968 (1-833-GBT-4YOU).

Patients ages 4 to less than 12 experienced similar side effects as patients ages 12 and up.

WHAT SHOULD YOU KNOW BEFORE STARTING OXBRYTA?

Taking Oxbryta