A new injected drug Simponi, or golimumab, has received the approval of the US Food and Drug Administration for the treatment of moderate-to-severe arthritis of three types - rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. However, like other similar drugs, Simponi's label will have a "black-box" warning about risk of tuberculosis and insidious fungal infections.
The clinical trials of Simponi show that once-a-month administration of the drug to arthritis patients brought about improvements in the common symptoms of the three forms of the ailment, in which the affected multiple joints cause stiffness, pain, and restricted movement.
Marketed by the Pennsylvania-based Centocor Ortho Biotech Inc, Simponi belongs to a particular class of drugs that aim at counterbalancing tumor necrosis factor-alpha
(TNF-alpha) - which is a protein is generally overproduced in the body as a result of chronic inflammatory diseases, and can bring about disquieting soreness and harm to bones, tissue, and cartilage.
Talking about the FDA approval of Simponi, Bob Rappaport, MD - director of the division of anesthesia, analgesia, and rheumatology products in the FDA's Center for Drug Evaluation and Research - said: "Today's approval provides another treatment option for patients with these three debilitating disorders. And the steps we're taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class."
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