Benzinga | Jan 10, 2022 09:07AM EST

Global Blood Therapeutics Says Co's Oxbryta Tablets For Oral Suspension Now Available For Patients With Sickle Cell Disease In U.S.

Global Blood Therapeutics, Inc. (GBT) (NASDAQ:GBT) today announced Oxbryta(r) (voxelotor) tablets for oral suspension, a new dispersible, once-daily tablet dosage form recently approved by the U.S. Food and Drug Administration (FDA), is now available through GBT's specialty pharmacy partner network in the United States.



On December 17, 2021, the FDA approved Oxbryta (voxelotor) tablets for the treatment of sickle cell disease (SCD) in children ages 4 to less than 12 years -- expanding the previously approved use of Oxbryta to treat SCD in patients ages 12 years and older in the U.S. The FDA also approved Oxbryta tablets for oral suspension, the new dispersible tablet dosage form suitable for patients ages 4 to less than 12 years. Oxbryta is the first and only approved medicine that directly targets sickle hemoglobin polymerization, the root cause of the sickling and destruction of red blood cells in SCD.

"The sickle cell disease community needs more innovative, safe and effective treatment options for this disease -- a fact central to GBT's mission," said Kim Smith-Whitley, M.D., executive vice president and head of research and development at GBT. "The FDA's recent approval of the new dispersible tablet dosage form of Oxbryta is an important advance for people and families affected by this devastating disease, and we are pleased to make this new dosage form available to patients by prescription. We are grateful to all those involved in ensuring that more sickle cell disease patients who need treatment with Oxbryta have access to it."

Oxbryta is now available by prescription in two dosage forms for patients 4 years and older based on the patient's age, weight, and ability to swallow tablets: 500 mg tablets and 300 mg tablets for oral suspension. The 300 mg dispersible tablets for oral suspension are available in bottles of 60 and 90 tablets. The dispersible tablets include grape flavoring and are intended to be dispersed in room-temperature clear drinks for ease of swallowing (such as drinking water or clear soda), making Oxbryta easier to take for patients who have difficulty swallowing whole tablets, particularly younger children.

GBT is committed to ensuring that patients who are prescribed Oxbryta can access their medicine. GBT Source Solutions(r) was established by GBT as a comprehensive program for patients who are prescribed Oxbryta that provides a wide range of practical, educational and financial support customized to each patient's needs. GBT Source Solutions provides support by reviewing insurance coverage options and explaining benefits; explaining specialty pharmacy benefits and working with the specialty pharmacies that coordinate shipments of Oxbryta; helping eligible, commercially insured patients with co-pay assistance; and helping appropriate patients stay on treatment with a nurse support team. More information is available at Oxbryta.com or 1-833-428-4968 (1-833-GBT-4YOU).