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Recent Pfizer Press Releases
Breakthrough Therapy Designation Designed by FDA to Expedite the Development and Review of Drugs and Vaccines Which May Demonstrate Substantial Improvement Over Available Therapy 1
Pfizer Inc. (NYSE:PFE) announced today that its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older.2 Pfizer expects to start Phase 3 trials in a few months.more...
Pfizer Inc. invites investors and the general public to view and listen
to a webcast of a conference call with investment analysts at 10 a.m.
EDT on Tuesday, October 30, 2018. The purpose of the call is to provide
an update on Pfizer’s results, as reflected in the company’s Third
Quarter 2018 Performance Report, to be issued that morning.
—Findings from sensitivity and post-hoc analyses were presented during a Late Breaking Clinical Trials Session at the Heart Failure Society of America 22 nd Annual Scientific Meeting— —Results of new analyses of all-cause mortality favored tafamidis across all sub-groups— —29% and 31% reduction in the risk of death observed in wild-type and hereditary sub-groups, respectively—
Pfizer Inc. (NYSE:PFE) announced today that additional sensitivity and post-hoc analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) study provide further detail on the effect of tafamidis across wild-type, hereditary, and New York Heart Association (NYHA) class sub-groups of patients with transthyretin amyloid cardiomyopathy (ATTR-CM).1 Tafamidis is the only investigational treatment that has completed a Phase 3 trial evaluating its safety and efficacy for the treatment of ATTR-CM.1 ATTR-CM is a rare, fatal, and underdiagnosed condition associated with progressive heart failure for which there are currently no approved pharmacologic treatments.2more...
Pfizer Inc. (NYSE:PFE) today announced results from its Phase 2a study
of PF-06651600, an oral Janus kinase (JAK) 3 inhibitor, and PF-06700841,
a tyrosine kinase (TYK) 2/JAK1 inhibitor, compared to placebo, in
patients with moderate to severe alopecia areata (AA), an autoimmune
disease characterized by hair loss and often associated with profound
psychological consequences. Both JAK inhibitors met the primary efficacy
endpoint in improving hair regrowth on the scalp relative to baseline at
week 24 (33.6 points and 49.5 points for JAK3 and TYK2/JAK1,
respectively) as measured by the Severity of Alopecia Tool (SALT) score
(100 point scale). The findings were presented during a Late-Breaking
News session at the 27th European Academy of Dermatology and Venereology
(EADV) Congress in Paris, France.
- First positive Phase III immunotherapy trial in combination with a tyrosine kinase inhibitor (TKI) in any tumor type
- Results significant in both PDL1+ and all-comer populations
- Alliance plans to pursue a regulatory submission in the US and discussions with other health authorities based on interim results for progression-free survival
- Trial will continue for the other primary endpoint of overall survival; detailed results to be submitted for presentation at an upcoming medical congress
Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced positive top-line results from the pivotal Phase III JAVELIN Renal 101 study evaluating BAVENCIO® (avelumab) in combination with INLYTA® (axitinib), compared with SUTENT® (sunitinib) as initial therapy for patients with advanced renal cell carcinoma (RCC).more...
Pfizer Inc. invites investors and the general public to listen to a
webcast of a discussion with Frank D’Amelio, Executive Vice President,
Business Operations, and Chief Financial Officer, at the Morgan Stanley
16th Annual Global Healthcare Conference on Thursday,
September 13, 2018 at 2:55 p.m. Eastern Daylight Time.
Phase II data accepted for late-breaker news session at 2018 EADV Congress
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced its investigational oral Janus
kinase 3 (JAK3) inhibitor PF-06651600 received Breakthrough
Therapy designation from the U.S. Food and Drug Administration (FDA) for
the treatment of patients with alopecia areata, a chronic autoimmune
skin disease that causes hair loss on the scalp, face, or body.1,2
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that it is terminating two
ongoing clinical studies evaluating domagrozumab (PF-06252616) for the
treatment of Duchenne muscular dystrophy (DMD): a Phase 2 safety and
efficacy study (B5161002) and an open-label extension study (B5161004).
The Phase 2 study (B5161002), did not meet its primary efficacy
endpoint, which was to demonstrate a difference in the mean change from
baseline in 4 Stair Climb (in seconds) following one year of treatment
with domagrozumab as compared to placebo in patients with DMD. Further
evaluation of the totality of evidence including secondary endpoints did
not support a significant treatment effect. The decision comes after a
thorough review of data available at the time of the primary analysis,
which evaluated all study participants after one year of treatment, as
well as those participants who were in the trial beyond one year. The
studies were not terminated for safety reasons. Pfizer will continue to
review the data to better understand any insights they may provide, and
will share results with the scientific and patient community.
ATTR-ACT Showed that Tafamidis Significantly Reduced the Combination of All-cause Mortality and Cardiovascular-related Hospitalizations Data Showed a 30% Reduction in the Risk of Mortality and 32% Reduction in the Rate of Cardiovascular-related Hospitalizations with Tafamidis in People with Transthyretin Amyloid Cardiomyopathy versus Placebo
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today the primary results from the
Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study, which
showed tafamidis significantly reduced the hierarchical combination of
both all-cause mortality and frequency of cardiovascular-related
hospitalizations compared to placebo over a 30-month period (P=0.0006)
in patients with wild-type or variant (hereditary) transthyretin amyloid
cardiomyopathy (ATTR-CM).1 ATTR-CM is a rare, fatal, and
underdiagnosed condition associated with progressive heart failure for
which there are no approved pharmacologic treatments.2,3
Amendments accelerate anticipated primary completion dates for both ARCHES and EMBARK trials
NEW YORK & TOKYO--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503, President and
CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced amendments to
the protocols for two registrational Phase 3 trials, ARCHES and EMBARK,
designed to evaluate the safety and efficacy of XTANDI®
(enzalutamide) in men with hormone-sensitive prostate cancer (HSPC).
These amendments accelerate timelines for the anticipated primary
completion dates of both trials.
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts on Monday, August 27, 2018 at 9:00 a.m. EDT. The purpose of the call is to review the Tafamidis data presentation at the ESC Congress 2018 organized by the European Society of Cardiology.more...
Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC) has approved XELJANZ® (tofacitinib citrate) 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.1 XELJANZ is the first and only oral therapy and Janus kinase (JAK) inhibitor to be approved for this patient population.more...
Second-Quarter 2018 Revenues of $13.5 Billion, Reflecting 2% Operational Growth Second-Quarter 2018 Reported Diluted EPS(1) of $0.65, Adjusted Diluted EPS(2) of $0.81 Raised 2018 Financial Guidance for Adjusted Diluted EPS(2) by $0.05 to a Range of $2.95 to $3.05 Lowered Midpoint of 2018 Revenue Guidance Range by $500 Million Solely to Reflect Recent Unfavorable Changes in Foreign Exchange Rates
Pfizer Inc. (NYSE: PFE) reported financial results for second-quarter 2018 and raised 2018 financial guidance for Adjusted diluted EPS(2).more...
The European Commission decision marks the approval of Pfizer’s first therapeutic oncology biosimilar
Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has approved TRAZIMERA™,1 a biosimilar to Herceptin®* (trastuzumab), for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 This approval follows the recommendation from the Committee for Medicinal Products for Human Use in May 2018.1more...
Pfizer today announced it will increase its commitment to U.S. manufacturing with a $465 million investment to build one of the most technically advanced sterile injectable pharmaceutical production facilities in the world in Portage, Michigan. This U.S. investment will strengthen Pfizer’s capability to produce and supply critical, life-saving injectable medicines for patients around the world.more...
NIVESTYM™, a biosimilar to Neupogen ® (filgrastim), is Pfizer’s fourth biosimilar to be approved by the FDA
Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product.more...
Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that a 16-week Phase 3 study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. The study demonstrated that patients who received two doses of tanezumab separated by eight weeks experienced a statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA, compared to those receiving placebo. Tanezumab is part of an investigational class of pain medications known as nerve growth factor (NGF) inhibitors and in addition to OA pain, is being evaluated for chronic low back pain (CLBP) and cancer pain (due to bone metastases).more...
Phase 3 lead-in study initiated following completion of the transfer of Spark Therapeutics’ hemophilia B gene therapy program to Pfizer
NEW YORK & PHILADELPHIA--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) and Spark Therapeutics (NASDAQ:ONCE) announced today that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the usual care setting. The factor IX prophylaxis efficacy data obtained in the lead-in study will serve as the within-subject control group for those patients that enroll into the next part of the Phase 3 study, which will evaluate the investigational gene therapy fidanacogene elaparvovec for the treatment of hemophilia B. The interventional portion of this pivotal Phase 3 study will enroll patients who have completed at least six months in the lead-in study. Fidanacogene elaparvovec is the official United States Adopted Name (USAN) and will become the Recommended International Nonproprietary Name (INN) for the therapy formerly known as SPK-9001 and PF-06838435.more...
First and Only Oral Treatment FDA-Approved for Both Non-Metastatic and Metastatic CRPC
TOKYO & Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. The FDA action broadens the indication for XTANDI to men with castration-resistant prostate cancer (CRPC), now including men with non-metastatic CRPC. This approval makes XTANDI the first and only oral medication FDA-approved for both non-metastatic and metastatic CRPC. XTANDI was first approved by the FDA in 2012 for the treatment of patients with metastatic CRPC who had previously received docetaxel, and was granted approval in 2014 for chemotherapy-naïve men with metastatic CRPC.more...