Simponi--A New Anti-TNF-alpha Monoclonal Antibody--Garners FDA Approval.
The FDA has approved Johnson and Johnson’s Simponi (golimumab), a new treatment for adults with moderate-to-severe rheumatoid arthritis , psoriatic arthritis, and ankylosing spondylitis. Unlike Enbrel, Remicade and Humira, other anti-TNF-alpha monoclonal antibody products—which require multiple monthly intravenous infusions—Simponi is injected under the skin and requires only a single monthly injection.
Simponi is intended for use in combination with the immune-suppressing drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.
In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.
Like other anti-TNF-alpha monoclonal antibody products, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and serious fungal infections with use of the drug. The most common side effects of Simponi include upper respiratory tract infection, sore throat, and nasal congestion.
I have no doubt that Simponi will provide much-needed relief to patients suffering from immune arthritis. However, I think that the marketing folks at J& J could have come up with a better name—it reminds me of Spumoni (the Italian ice cream) and The Simpsons television program. But, then again, the name is distinctive and easy to remember!
Until next time...
Good Luck and Good Job Hunting!!!!!!!!!!!
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The buzz and promise of biotechnology is the likely cause of the buying frenzy that big pharma has been on lately. Word on the street is that biotechnology products are innovative, have a higher return on investment (ROI) and are generally perceived to be “better” than conventional small molecule drugs. I agree that biotechnology products are certainly innovative and the gargantuan ROIs are titillating. But, are biotechnology products always safer and more efficacious than extant small molecule drugs? According to a recent study–maybe not! 