Pfizer Voluntarily Withdraws All Lots of Sickle Cell Disease Treatment OXBRYTA® (voxelotor) From Worldwide Markets
“The safety and well-being of patients is of the utmost importance to
Patients, physicians, pharmacists, or other healthcare professionals with additional questions about OXBRYTA should contact Pfizer Medical Information 1-800-438-1985. The company will keep patients, regulatory authorities, investigators and clinicians informed about actions and appropriate next steps for OXBRYTA.
The company does not anticipate that this event will impact its full-year 2024 financial guidance.
About Sickle Cell Disease
SCD is a lifelong, debilitating inherited blood disorder in which hemoglobin S polymerization leads to red blood cell sickling resulting in vascular inflammation and hemolytic anemia. Vascular inflammation, together with sickled RBC’s can lead to acute pain crises, or vaso-occlusive crises, and progressive end organ damage, including stroke. Complications of SCD begin in early childhood and are associated with shortened life expectancy. Early intervention and treatment of SCD have shown potential to modify the course of this disease, reduce symptoms and events, prevent long-term organ damage, and extend life expectancy.
Historically, there has been a high unmet need for therapies that address the root cause of SCD and its acute and chronic complications. While rare in developed markets, there are 4.5 million people living with SCD globally and more than 45 million people living with the sickle cell trait. SCD occurs particularly among those whose ancestors are from sub-Saharan Africa, though it also occurs in people of Hispanic, South Asian, Southern European and Middle Eastern ancestry.
About OXBRYTA® (voxelotor)
OXBRYTA (voxelotor) is an oral, once-daily therapy for patients with sickle cell disease (SCD). OXBRYTA works by increasing hemoglobin’s affinity for oxygen. OXBRYTA inhibits sickle hemoglobin polymerization and the resultant sickling and destruction of red blood cells leading to hemolysis and hemolytic anemia, which are primary pathologies faced by every single person living with SCD.
In 2019, the
OXBRYTA was granted Priority Medicines (PRIME) designation by the
Important Safety Information
OXBRYTA should not be taken if the patient has 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. OXBRYTA can cause serious side effects, including serious allergic reactions. Patients should tell their healthcare provider or get emergency medical help right away if they get rash, hives, shortness of breath (difficult breathing) or swelling of the face.
The most common side effects of OXBRYTA include headache, diarrhea, stomach-area (abdominal) pain, nausea, rash or hives, and 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, and headache. These are not all the possible side effects of OXBRYTA. Before taking OXBRYTA, patients should tell their healthcare provider about all medical conditions, including if they have liver problems; if they are pregnant or plan to become pregnant as it is not known if OXBRYTA can harm an unborn baby; or if they are breastfeeding or plan to breastfeed as it is not known if OXBRYTA can pass into breastmilk or if it can harm a baby. Patients should not breastfeed during treatment with OXBRYTA and for at least 2 weeks after the last dose.
Patients should tell their healthcare provider about all the medicines they 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 and may affect the results of certain blood tests.
Patients are advised to call their doctor for medical advice about side effects. Side effects can be reported to FDA at 1-800-FDA-1088. Side effects can also be reported at 1-833-428-4968.
Full Prescribing Information for OXBRYTA is available at OXBRYTA.com.
About
At
DISCLOSURE NOTICE:
The information contained in this release is as of
This release contains forward-looking information about a voluntary withdrawal of all lots of OXBRYTA (voxelotor) from worldwide markets, including the anticipated impact on the company’s full-year 2024 guidance, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the future of OXBRYTA (voxelotor), as well as uncertainties related to other sickle cell disease assets in our portfolio; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of OXBRYTA (voxelotor) or other sickle cell disease assets in our portfolio; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer’s business and prospects, legal proceedings, adverse developments in Pfizer’s markets, or adverse developments in the
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended
Category: Prescription Medicines
View source version on businesswire.com: https://www.businesswire.com/news/home/20240925201472/en/
Media Contact:
PfizerMediaRelations@Pfizer.com
+1 (212) 733-1226
Investor Contact:
IR@Pfizer.com
+1 (212) 733-4848
Source: