Pfizer Inc. (NYSE: PFE) announced today that it is voluntarily
withdrawing all lots of OXBRYTA® (voxelotor) for the treatment of
sickle cell disease (SCD) at this time, in all markets where it is
approved. Pfizer is also discontinuing all active voxelotor
clinical trials and expanded access programs worldwide.
Pfizer's decision is based on the totality of clinical data that
now indicates the overall benefit of OXBRYTA no longer outweighs
the risk in the approved sickle cell patient population. The data
suggest an imbalance in vaso-occlusive crises and fatal events
which require further assessment. Pfizer has notified regulatory
authorities about these findings and its decision to voluntarily
withdraw OXBRYTA from the market and discontinue distribution and
clinical studies while further reviewing the available data and
investigating the findings.
“The safety and well-being of patients is of the utmost
importance to Pfizer, and we believe this action is in the best
interest of patients,” said Aida Habtezion, Chief Medical Officer
and Head of Worldwide Medical and Safety at Pfizer. “Our primary
concern is for patients who suffer from SCD, which remains a very
serious and difficult-to-treat disease with limited treatment
options. We advise patients to contact their physicians to discuss
alternative treatment while we continue to investigate the findings
from our review of the data.”
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 U.S. Food and Drug Administration (FDA) granted
accelerated approval for OXBRYTA tablets for the treatment of SCD
in adults and children ages 12 years and older. In December 2021,
the FDA expanded the approved use of OXBRYTA for the treatment of
SCD in patients 4 years of age and older in the U.S.
OXBRYTA was granted Priority Medicines (PRIME) designation by
the European Medicines Agency (EMA) and designated an orphan
medicinal product for the treatment of patients with SCD by the
European Commission (EC). In February 2022, the EC granted
Marketing Authorization for OXBRYTA for the treatment of hemolytic
anemia due to SCD in adult and pediatric patients 12 years of age
and older as monotherapy or in combination with hydroxycarbamide
(hydroxyurea). Since its first approval in 2019, OXBRYTA has been
approved in over 35 countries globally.
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 Pfizer: Breakthroughs That Change Patients’
Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
175 years, we have worked to make a difference for all who rely on
us. We routinely post information that may be important to
investors on our website at www.Pfizer.com. In addition, to learn
more, please visit us on www.Pfizer.com and follow us on X at
@Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer.
DISCLOSURE NOTICE:
The information contained in this release is as of September 25,
2024. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new
information or future events or developments.
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 U.S. or global capital markets, credit markets,
regulatory environment or economies generally; uncertainties
regarding the impact of COVID-19 on our business, operations and
financial results; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2023, and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results,” as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
Category: Prescription Medicines
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Pfizer (NYSE:PFE)
過去 株価チャート
から 10 2024 まで 11 2024
Pfizer (NYSE:PFE)
過去 株価チャート
から 11 2023 まで 11 2024