• Regulatory NewsRegulatory News

    EMA Follows FDA Warning on Xeljanz Blood Clot Risks

    The European Medicines Agency (EMA) on Wednesday warned patients and healthcare professionals against exceeding the recommended dose of Pfizer’s rheumatoid arthritis (RA) drug Xeljanz (tofacitinib) due to an increased risk of blood clots forming in the lungs.   EMA’s warning comes less than a month after the US Food and Drug Administration (FDA) issued a similar warning after identifying the risk during an ongoing postmarketing safety study for the drug. In the lat...
  • Regulatory NewsRegulatory News

    EMA Adopts Guideline on Clinical Trials for Rheumatoid Arthritis Treatments

    The European Medicines Agency (EMA) on Wednesday announced the adoption of a guideline, first drafted in 2011, on the clinical evaluation of medicinal products in the treatment of the autoimmune disease rheumatoid arthritis (RA). "Currently, several biomarkers which may predict disease progression and response are under development. In the future, this may lead to a more individually targeted treatment approach," the guideline said. "Despite significant advances in...
  • Draft Guidance Calls for Lengthier Premarket Safety Databases for Rheumatoid Arthritis Treatments

    The US Food and Drug Administration (FDA) has published a new draft guidance document regarding the development of pharmaceutical and biological products meant to treat rheumatoid arthritis, a painful and debilitating autoimmune disease that affects a patient's mobility. Background Rheumatoid arthritis has been something of a minefield for FDA and industry in the last decade. In 2004, pharmaceutical giant Merck voluntarily withdrew its blockbuster drug Vioxx, a non-ster...
  • Pfizer's Tofacitinib Wins Regulatory Approval Ahead of PDUFA Date

    • 07 November 2012
    After a lengthy back and forth, Pfizer's potential rheumatoid arthritis blockbuster Xeljanz (tofacatinib) has won approval from the US Food and Drug Administration (FDA), the agency announced on 6 November. Rheumatoid arthritis (RA) is a disease in which the body's immune system attacks otherwise healthy tissue, causing joint and tissue swelling and damage. Xeljanz is expected to fill a large niche market for patients with RA who did not respond to methotrexate, also...
  • Pfizer Withdraws Indication for RA Drug After It Fails to Complete Required Study

    The US Food and Drug Administration (FDA) said Pfizer is withdrawing an indication for its rheumatoid arthritis (RA) drug Celebrex after Pfizer indicated it would not be able to complete a mandated postmarketing study to verify the new indication. Celebrex had received approval for its indication to treat familiar adenomatous polyposis (FAP) in 1999 under FDA's accelerated approval pathway. The inherited condition causes polyps to form in the large intestine, often causi...
  • Merck Settles Vioxx Criminal Charges With US for $322 Million

    US pharmaceutical manufacturer Merck & Co. has settled criminal charges over the company's marketing of its painkiller drug Vioxx, reports Bloomberg . Merck will pay a $321.6 million criminal fine after US District Judge Patti Saris approved the settlement. This fine is in addition to a $628.3 million in civil claims paid out in November 2011, reports The Philadelphia Inquirer . Merck was charged with promoting Vioxx, a rheumatoid arthritis drug, illegally despite...
  • FDA Panel Recommends Restarting Testing of Controversial Pain Drugs

    An US Food and Drug Administration (FDA) Advisory Committee Panel recommended clinical trials testing anti-nerve growth factor inhibitors (anti-NGF inhibitors) be allowed to continue, with certain precautions, reports The Associated Press. The Arthritis Advisory Committee (AAC) voted 21-0 on 12 March to recommend that research continue in light of the unmet needs of patients. Panelists noted many patients do not respond to existing pain medications such as aspirin a...
  • Report: Pharma-Funded Science Not Necessarily Biased Towards Drugmakers

    • 27 February 2012
    A report published in the journal Arthritis & Rheumatism showed no statistical significance between arthritis research funded by pharmaceutical manufacturers and research funded by non-profits or government entities. Thirty-seven of 49 trials (75.5%) sponsored by pharmaceutical manufacturers reported positive outcomes compared to 11 of 16 (68.75%) studies funded by nonprofits, government entities or foundations, reports Reuters . The trials all studied rhe...