• Contemporary ClinicContemporary Clinic
  • OTC GuideOTC Guide
  • Pharmacy Times
  • PTCEPTCE
  • Pharmacist Moms GroupPharmacist Moms Group
News
All News
FDA Updates
Press Releases
Media
All Videos
Digital Detail
Independent Corner
Insights
Interviews
MEDcast
Medical World News
Microsites
Peer Exchange
Perfect Consult
Podcasts
Practice Pearls
Sponsored Webcast
Student Voices
Webinars/Webcasts
Conferences
Conference Coverage
Conference Listing
Publications
Pharmacy Times
Pharmacy Practice in Focus: Oncology
Pharmacy Practice in Focus: Health Systems
Pharmacy Careers
All Publications
About the Publications
Author Submission
Submit to Pharmacy Practice in Focus: Oncology
Submit to Pharmacy Practice in Focus: Health Systems
Become a Peer Reviewer
Supplements & Featured Publications
Clinical
503B Compounding Pharmacy
ADHD
Allergy
Alzheimer Disease
Anxiety
Asthma
Atopic Dermatitis
Biosimilars
Bipolar Disorder
Brain Health
Breast Cancer
C. Difficile
COPD
COVID-19
Cardiovascular Health
Cervical Cancer
Cholangiocarcinoma
Cholesterol
Chronic Kidney Disease
Chronic Lymphocytic Leukemia
Classical Hematology
Colorectal Cancer
Continuous Glucose Monitoring
Cough and Cold
Depression
Dermatology
Diabetes
Digestive Health
Dry Eye Disease
Epilepsy
Eye Care
Flu
Future of Pharmacy
Gastrointestinal Cancer
Gastrointestinal Health
Gout
HER2 Breast Cancer
HIV
Heart Failure
Hematology
Hepatitis/MASH
Immunization
Immuno-oncology
Immunoglobulins
Infectious Disease
Lung Cancer
Lymphoma
Macular Degeneration
Mental Health
Migraine
Movement Disorders
Multiple Myeloma
Multiple Sclerosis
Myelofibrosis
Neurology
Neutropenia
Osteoporosis
Ovarian Cancer
Pain Management
Parkinson Disease
Pediatrics
Pharmacy Heroes
Pharmacy Management
Pneumococcal
PrEP
Prostate Cancer
Psoriasis
Psoriatic Arthritis
Psychedelics
Reimbursement
Reproductive Health
Respiratory Syncytial Virus
Rheumatoid Arthritis
Schizophrenia
Shingles
Skin Cancer
Sleep
Travel Vaccines
Veterinary Pharmacy
Vitamins and Supplements
Weight Management
Women's Health
Events
Upcoming Events
Upcoming Webinars
CE
Resources
Clinical Forum
Cou-Co
Educated Patient
Information for the Pharmacist
Interactive Tools
Partners
Sponsored
Whiteboards
Subscribe
logo
Spotlight
Community/RetailHospitalOncologyPharmacy TechnicianStudent
Clinical Role
Community/RetailHospitalOncologyPharmacy TechnicianSpecialty PharmacyStudent
Clinical
CoronavirusBrain HealthCardiovascular HealthDermatologyDiabetesFluHeart FailureHepatitis/MASHImmunizationMigrainePneumococcalVitamins and Supplements
Supplement Spotlight
October 2023 Pharmacy Technician Edition
All News
FDA Updates
Press Releases
All Videos
Digital Detail
Independent Corner
Insights
Interviews
MEDcast
Medical World News
Microsites
Peer Exchange
Perfect Consult
Podcasts
Practice Pearls
Sponsored Webcast
Student Voices
Webinars/Webcasts
Conference Coverage
Conference Listing
Pharmacy Times
Pharmacy Practice in Focus: Oncology
Pharmacy Practice in Focus: Health Systems
Pharmacy Careers
All Publications
About the Publications
Author Submission
Submit to Pharmacy Practice in Focus: Oncology
Submit to Pharmacy Practice in Focus: Health Systems
Become a Peer Reviewer
Supplements & Featured Publications
503B Compounding Pharmacy
ADHD
Allergy
Alzheimer Disease
Anxiety
Asthma
Atopic Dermatitis
Biosimilars
Bipolar Disorder
Brain Health
Breast Cancer
C. Difficile
COPD
COVID-19
Cardiovascular Health
Cervical Cancer
Cholangiocarcinoma
Cholesterol
Chronic Kidney Disease
Chronic Lymphocytic Leukemia
Classical Hematology
Colorectal Cancer
Continuous Glucose Monitoring
Cough and Cold
Depression
Dermatology
Diabetes
Digestive Health
Dry Eye Disease
Epilepsy
Eye Care
Flu
Future of Pharmacy
Gastrointestinal Cancer
Gastrointestinal Health
Gout
HER2 Breast Cancer
HIV
Heart Failure
Hematology
Hepatitis/MASH
Immunization
Immuno-oncology
Immunoglobulins
Infectious Disease
Lung Cancer
Lymphoma
Macular Degeneration
Mental Health
Migraine
Movement Disorders
Multiple Myeloma
Multiple Sclerosis
Myelofibrosis
Neurology
Neutropenia
Osteoporosis
Ovarian Cancer
Pain Management
Parkinson Disease
Pediatrics
Pharmacy Heroes
Pharmacy Management
Pneumococcal
PrEP
Prostate Cancer
Psoriasis
Psoriatic Arthritis
Psychedelics
Reimbursement
Reproductive Health
Respiratory Syncytial Virus
Rheumatoid Arthritis
Schizophrenia
Shingles
Skin Cancer
Sleep
Travel Vaccines
Veterinary Pharmacy
Vitamins and Supplements
Weight Management
Women's Health
Upcoming Events
Upcoming Webinars
CE
Clinical Forum
Cou-Co
Educated Patient
Information for the Pharmacist
Interactive Tools
Partners
Sponsored
Whiteboards
Subscribe
Advertisement

CLINICAL ROLE -

Community/Retail
| Hospital
| Oncology
| Pharmacy Technician
| Student

Article

May 10, 2012

Pfizer's New Oral Drug for Rheumatoid Arthritis Recommended for Approval

Author(s):

Randi Hernandez, Associate Editor/Online

The committee voted 8-2 to recommend approval of the investigational agent tofacitinib, and an FDA decision could come as early as August.

The committee voted 8-2 to recommend approval of the investigational agent tofacitinib, and an FDA decision could come as early as August.

An advisory panel to the FDA voted yesterday on whether or not to recommend approval of the drug tofacitinib, Pfizer’s new oral drug for the treatment of rheumatoid arthritis (RA) in patients who have had inadequate response to 1 or more disease-modifying antirheumatic drugs (DMARDs).

The panel voted that the drug should be approved, but stated that limits should be put into place on the types of patients who should be offered the therapy. Some panel members suggested that patients should only have access to the lower of the 2 proposed dosage strengths for tofacitinib until more safety data are available for the drug.

The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of August 2012. If approved by the FDA, tofacitinib would be the first new oral DMARD for RA in more than 10 years and the first RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors.

Pfizer’s drug works in a different way than other treatments by inhibiting the production of inflammatory mediators. It would be the first oral treatment available for RA if approved.

Although the drug appears to ease the symptoms of RA, the studies did not prove that the treatment halts the progression of the disease, as noted by an article in The New York Times. In addition, there were multiple safety concerns surrounding the use of the drug, including 4 deaths during 1 of the trials. Only 1 of these deaths, according to researchers conducting the trial, was related to tofacitinib.

The risk of serious adverse affects with the drug is not surprising, as many of the drugs used to treat autoimmune diseases carry strong warnings about the increased risk of infections such as tuberculosis, and most of the other drugs used to treat RA are associated with the same risks. John H. Klippel, MD, president of the Arthritis Foundation, told The New York Times, “People who have that disease, in general, are willing to accept the risk of even serious adverse effects from the drugs if they can find drugs that are going to alter the course of the disease.”

Newsletter

Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights.

Subscribe Now!
Related Videos
Inflammation concept, inflammated human tissues 3d rendering - Image credit: picture-waterfall | stock.adobe.com
Tired scared retiree man holding chest with anginal symptoms, pallor and diaphoresis at home. Suffering male with cardiac origin pain, prexcordial pressure, arrhythmia risk, urgent medical attention - Image credit: DimaBerlin | stock.adobe.com
Image credit: Sebastian Kaulitzki | stock.adobe.com
Menoapuse spelled with wooden blocks -- Image credit: loran4a | stock.adobe.com
Related Content
Advertisement
X-ray image of kidneys with CKD -- Image credit: Crystal light | stock.adobe.com
July 2nd 2025

FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia

Gillian McGovern, Associate Editor
Pharmacy Focus: Pharmacists' Role in Medical Cannabis Counseling and Patient Education
February 28th 2025

Pharmacy Focus: Pharmacists' Role in Medical Cannabis Counseling and Patient Education

Luke Halpern, Assistant Editor Jill Simonian, PharmD Codi Peterson, PharmD, MS
FDA Approved Food and Drug Administration concept. Person with FDA icon on virtual screen for Health product standards control system.
June 30th 2025

FDA Approves Emapalumab-Lzsg as First-Ever Treatment for Macrophage Activation Syndrome in Still Disease

Luke Halpern, Assistant Editor
Pharmacy Focus: World Psychedelics Day
June 14th 2024

Pharmacy Focus: World Psychedelics Day

Ashley Gallagher, Editor
Creative layout of colorful pills and capsules on blue background. Minimal medical concept. Pharmaceutical, Covid-19 or Coronavirus. Flat lay, top view
June 26th 2025

Mid-Year Roundup: FDA’s Novel Retail and Specialty Drug Approvals in 2025

Luke Halpern, Assistant Editor
Water coming from a faucet - Image credit: Ajax9 | stock.adobe.com
June 25th 2025

Is Fluoride Friend or Foe?

Jim Ruble, PharmD, JD
Related Content
Advertisement
X-ray image of kidneys with CKD -- Image credit: Crystal light | stock.adobe.com
July 2nd 2025

FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia

Gillian McGovern, Associate Editor
Pharmacy Focus: Pharmacists' Role in Medical Cannabis Counseling and Patient Education
February 28th 2025

Pharmacy Focus: Pharmacists' Role in Medical Cannabis Counseling and Patient Education

Luke Halpern, Assistant Editor Jill Simonian, PharmD Codi Peterson, PharmD, MS
FDA Approved Food and Drug Administration concept. Person with FDA icon on virtual screen for Health product standards control system.
June 30th 2025

FDA Approves Emapalumab-Lzsg as First-Ever Treatment for Macrophage Activation Syndrome in Still Disease

Luke Halpern, Assistant Editor
Pharmacy Focus: World Psychedelics Day
June 14th 2024

Pharmacy Focus: World Psychedelics Day

Ashley Gallagher, Editor
Creative layout of colorful pills and capsules on blue background. Minimal medical concept. Pharmaceutical, Covid-19 or Coronavirus. Flat lay, top view
June 26th 2025

Mid-Year Roundup: FDA’s Novel Retail and Specialty Drug Approvals in 2025

Luke Halpern, Assistant Editor
Water coming from a faucet - Image credit: Ajax9 | stock.adobe.com
June 25th 2025

Is Fluoride Friend or Foe?

Jim Ruble, PharmD, JD
Consent Preferences
About Us
Clinical Forums
Advertise
Contact Us
Editorial Staff
Privacy Policy
Terms & Conditions
Do Not Sell My Information
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.