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The FDA Arthritis Advisory Committee voted 1-12 today against recommending approval of the biologics license application for sirukumab injection for the treatment of moderately to severely active rheumatoid arthritis among patients who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs.The meeting focused on one phase 2 dose ranging study and three phase 3 studies which assessed the efficacy and safety of sirukumab, an interleukin-6 (IL-6) inhibitor with the proposed trade name Plivensia (Janssen Biotech Inc.). The results showed sirukumab at doses of 50 mg every 4 weeks and 100 mg every 2 weeks effectively reduced the symptoms, delayed the progression of structural damage and improved patient reported outcomes of rheumatoid arthritis (RA), and had a similar safety profile to other biologics used in the management of RA. Janssen Biotech proposed sirukumab 50 mg every 4 weeks as the only dose for the treatment of patients with RA based on the efficacy and safety data.NEXT ARTICLE
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...
According to the National Arthritis Data Workgroup, an estimated 6 million people in the United States report having experienced gout at some point in their lives. In fact, gout is the most common form of inflammatory arthritis in men over the age of 40....
The field encompassing therapeutic materials produced using biological means, including recombinant DNA technology. Biotherapeutics, also known as biotech drugs or biologics, are therapies derived from living organisms. By harnessing these living cells...