Enbrel shows positive effects for arthritis sufferers in longterm therapy
SAN FRANCISCO A biologic drug may be the first of its kind to show sustained improvements in multiple measures of efficacy in moderate to severe rheumatoid arthritis patients completing up to 10 years of therapy, the companies that made the drug said Monday.
Amgen and Wyeth Pharmaceuticals said the new data on the drug Enbrel (etanercept) are being presented at the American College of Rheumatology Scientific Meeting in San Francisco.
“The long-term evaluation of medications for the treatment of RA is important because this is a chronic, progressive disease that requires continuous treatment to inhibit the progression of further joing damage,” said Mark Genovese of the Stanford University Medical Center in Palo Alto, Calif. “These 10-year data demonstrate that improvements in disease activity measures were maintained, and the safety profile was consistent over time.”
Enbrel is a soluble form of the human tumor necrosis factor receptor. The Food and Drug Administration approved it in 2004 for treating rheumatoid arthritis and psoriasis in adults.
FDA launches new Web page to provide safety information on prescription drugs
WASHINGTON The Food and Drug Administration announced Wednesday that it had launched a Web page to provide consumers and healthcare professionals with a single source of safety information about prescription drugs.
The page, www.fda.gov/cder/drugsafety.htm, provides links to information in categories such as drug labeling, drugs with risk evaluation and mitigation strategies, regulations and guidance documents and warning letters, import alerts, recalls, market withdrawals and safety alerts.
“By placing Web links to these up-to-date resources on a single page, we’re helping consumers and healthcare professionals find drug safety information faster and easier,” said Dr. Paul Seligman, associate director of safety policy and communication in the FDA’s Center for Drug Evaluation and Research. “This type of communication is aimed at helping consumers and healthcare professionals make well-informed decisions about medication use.”
FDA approves generic version of Epivir
WASHINGTON The Food and Drug Administration has granted tentative approval to Indian drug maker Macleods Pharmaceuticals’ generic version of GlaxoSmithKline’s HIV drug Epivir (lamivudine), FDA records show.
The drug would be available as 150 mg and 300 mg tablets, but cannot be marketed in the United States because of patent protection.
GSK’s patent for lamivudine will expire in 2010. Epivir had sales of $246.85 million in 2007, according to GSK financial records.