February 2008
Humira Approved for JRA
Posted 2/27/08
The FDA has approved adalimumab (Humira) as a treatment for the symptoms of moderate to severe juvenile rheumatoid arthritis (JRA) in patients age 4 and older. The approval is based on results from a 48-week Phase III clinical trial and subsequent open-label extension study enrolling 171 JRA patients age 4–17. Fewer children treated with adalimumab in the study experienced disease flare compared with those taking placebo.
This indication is the sixth Humira has received since 2002. The other approved indications are moderate to severe rheumatoid arthritis in adults, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and moderate to severe chronic plaque psoriasis.
Generic Versions of Fosamax Approved
Posted 2/21/08
The U.S. Food and Drug Administration approved the first generic versions of Fosamax (alendronate sodium tablets) on February 6. Alendronate sodium is used to treat osteoporosis, a condition that causes thinning and weakening of a person's bones.
Selective Steroids for RA
Posted 2/6/08
Swedish drugmaker Karo Bio has begun a three-year research collaboration with India-based Zydus Cadila to develop novel, selective glucocorticoid receptor modulators for the treatment of inflammatory diseases. Glucocorticoids are used to treat rheumatoid arthritis, inflammatory bowel disease, psoriasis and asthma. The drugmakers will work to develop glucocorticoids whose long-term use will not lead to side effects such as obesity, diabetes and osteoporosis.
