Oxbryta™ (voxelotor) tablets Now Approved
On behalf of GBT, we are happy to share that Oxbryta (pronounced ox-brye-ta) is now approved by the U.S. Food and Drug Administration (FDA). Oxbryta is a prescription medicine used for the treatment of sickle cell disease in adults and children 12 years of age and older.1 It is not known if Oxbryta is safe and effective in children below 12 years of age.1
This indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).2
This approval has been the result of years of collaboration with the community, and we are so grateful for your role in helping GBT get this to patients quickly!
1) Oxbryta is the brand name for voxelotor. This approval represents a historic one, as Oxbryta is the first sickle cell disease drug approved under both the Breakthrough Therapy and Accelerated Approval designations by the FDA.
· Voxelotor is a hemoglobin S (HbS) polymerization inhibitor.2
· Nonclinical studies suggest that voxelotor may inhibit red blood cell (RBC) sickling, improve RBC deformability, and reduce whole blood viscosity.2
· It is a prescription medicine (tablet) taken by mouth once daily, every day.1
2) Oxbryta should not be taken if a patient has had an allergic reaction to voxelotor or any of the ingredients in Oxbryta. Oxbryta can cause side effects including: headache, diarrhea, stomach (abdominal) pain, nausea, tiredness, rash and fever.1
Patient Support: GBT Source Solutions™
As part of GBT’s commitment to supporting access to care for patients, we have launched GBT Source Solutions, a resource center for patients who have been prescribed Oxbryta by their healthcare provider. GBT Source Solutions will provide support by:
· Reviewing insurance coverage options and explaining benefits.
· Coordinating shipment of Oxbryta and explaining Specialty Pharmacy benefits.
· Helping to pay for treatment with financial and co-pay assistance for eligible patients.
· Helping to stay on treatment with a nurse support team. The nurse support team is there to support product adherence, and not to replace a patient’s treatment plan. They do not provide medical advice or case management services.
Your organization plays a critical role in supporting patients, and we are very thankful for everything you do for people living with SCD. Your collaboration is critical to helping inform patients about Oxbryta and GBT’s patient support services for patients prescribed Oxbryta.
If a patient is interested in learning more about Oxbryta, they should consult their healthcare professional or visit www.Oxbryta.com.
We have attached in this email several resources. You may share these with patients, caregivers, and other members of your community.
Please feel free to reach out with any questions. We look forward to continuing our collaboration to help improve the lives of SCD patients and provide hope to our community.
INDICATION AND IMPORTANT SAFETY INFORMATION
What is OXBRYTA?
OXBRYTA is a prescription medicine used for the treatment of sickle cell disease in adults and children 12 years of age and older.
It is not known if OXBRYTA is safe and effective in children below 12 years of age.
This indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
IMPORTANT SAFETY INFORMATION
Do not take OXBRYTA if you 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.
If you are receiving exchange transfusions, talk to your healthcare provider about possible difficulties with the interpretation of certain blood tests when taking OXBRYTA.
Before taking OXBRYTA, tell your healthcare provider about all of your medical conditions, including if you:
· have liver problems
· are pregnant or plan to become pregnant. It is not known if OXBRYTA can harm your unborn baby.
· are breastfeeding or plan to breastfeed. It is not known if OXBRYTA can pass into your breastmilk and if it can harm your baby. Do not breastfeed during treatment with OXBRYTA and for at least 2 weeks after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how OXBRYTA works. OXBRYTA may also affect how other medicines work.
What are the possible side effects of OXBRYTA?
OXBRYTA can cause serious side effects, including:
Serious allergic reactions. Tell your healthcare provider or get emergency medical help right away if you get:
· shortness of breath
· swelling of the face
The most common side effects of OXBRYTA include:
· stomach (abdominal) pain
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 at 1-833-428-4968 (1-833-GBT-4YOU).
Keep OXBRYTA and all medicines out of the reach of children.
1 Patient Information Leaflet 11 2019
2 USPI 11 2019