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Manufacturer / Innovator:
USA
Regulatory Approval:
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Important Update — Oxbryta (voxelotor): Globally Withdrawn. Pfizer voluntarily withdrew Oxbryta from every market worldwide in September 2024. The decision followed a review of clinical trial and real-world data showing an imbalance of vaso-occlusive crises and fatal events in patients taking Oxbryta compared to placebo, leading Pfizer and regulators to conclude that the overall benefit-risk balance was no longer favorable. All Oxbryta clinical trials and expanded-access programs were discontinued at the same time. As a result, Oxbryta is no longer commercially available anywhere in the world, and NPP has no market from which to source it. This page is maintained for informational and historical reference only.
Before its withdrawal, Oxbryta (voxelotor) was approved for the treatment of sickle cell disease (SCD) in adult and pediatric patients 4 years of age and older, under an accelerated approval pathway based on hemoglobin response.
Oxbryta worked by binding to hemoglobin and inhibiting the polymerization process that causes red blood cells to sickle, aiming to reduce hemolysis and improve anemia in sickle cell disease patients.
Patients previously on Oxbryta, or those newly diagnosed with sickle cell disease, should speak with their treating hematologist promptly about currently available, approved treatment options, as continuing Oxbryta or restarting it is not recommended given the identified safety concerns.
Reason for Withdrawal — Increased Risk of Vaso-Occlusive Crises and Death: The withdrawal was prompted by data showing more vaso-occlusive crises and fatal events among patients taking Oxbryta compared to those on placebo, across clinical trials and post-marketing data. This is the primary safety concern that led to the drug's discontinuation, and it applies to all patients who may have residual supply.
While available, Oxbryta carried warnings for hypersensitivity reactions, including DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms), presenting as rash, hives, difficulty breathing, facial swelling, and elevated eosinophil counts.
Oxbryta was known to interfere with hemoglobin subtype measurement by HPLC methods, a consideration for any lab test results from the period a patient was taking it.
Patients with any remaining Oxbryta supply should not continue or restart the medicine and should consult their treating hematologist immediately regarding safe discontinuation and alternative treatment.
Because Oxbryta's approval has been withdrawn globally and the manufacturer, Pfizer, has discontinued production and all clinical/expanded-access programs, NPP's standard import process does not currently apply to this medicine — there is no authorized market from which it can be sourced.
We recommend patients work with their treating hematologist to identify currently available, approved alternative therapies for sickle cell disease. NPP's team can be contacted to discuss currently sourceable sickle cell disease treatments if needed.
Note: Because Oxbryta cannot currently be sourced, the standard 6-step import process used for other medicines on this site does not apply here.
Oxbryta is not currently available for import or sourcing through NPP, or through any other channel, anywhere in the world. Pfizer voluntarily withdrew Oxbryta globally in September 2024, following data showing an unfavorable benefit-risk balance, and has discontinued manufacturing.
Oxbryta was manufactured and marketed by Global Blood Therapeutics, Inc., a Pfizer company, prior to its withdrawal.
There is no market — regulated or otherwise — where Oxbryta remains approved and commercially available. NPP does not source or supply Oxbryta under any circumstances given this status.
NPP does not source or deliver Oxbryta, as it has been withdrawn from every market worldwide and is no longer manufactured. This section is retained for transparency and informational completeness rather than to describe an active service.
Patients with sickle cell disease should discuss currently available, approved alternative therapies with their treating hematologist, given the safety concerns that led to Oxbryta's withdrawal.
Oxbryta is not available for import or sourcing anywhere in India, or anywhere in the world, following its global withdrawal. The information below reflects where patients can seek guidance on currently available alternative therapies, not Oxbryta access.
Mumbai's hematology centers can advise patients on currently approved sickle cell disease treatment alternatives.
Delhi's major hospitals can connect patients with hematologists familiar with current sickle cell disease treatment options.
Bangalore's specialist network can discuss currently available alternative therapies for eligible patients.
Chennai-based hematology specialists can advise on current sickle cell disease treatment pathways.
Hyderabad's care institutions can support patients seeking guidance on current treatment alternatives.
Kolkata's specialist centers can help patients understand currently available treatment options.
Pune-based specialists can advise on current alternatives for sickle cell disease management.
Ahmedabad's specialty hospitals can guide patients toward currently approved treatment options.
Kochi's specialist units can assist patients in understanding current treatment alternatives.
Chandigarh's care centers can support patients from North India seeking current treatment guidance.
Jaipur's specialists can help patients navigate currently available treatment options.
Lucknow-based centers can assist patients in identifying current treatment alternatives.
Bhubaneswar's institutions can support patients seeking guidance on current options.
Guwahati's specialists can help coordinate guidance for patients across the Northeast.
NPP's team remains available to discuss currently sourceable alternative therapies for sickle cell disease across India.
Our specialists are here to guide you through every step of the medicine access process.
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