From FierceBiotech:
http://www.fiercebiotech.com/story/canadian-regulators-approve-golimumab/2009-04-13
From the article:
"Canadian regulators have approved Simponi (golimumab), a biologic
developed by Johnson & Johnson and Schering-Plough. The drug--an
update to the blockbuster Remicade--is indicated for severe rheumatoid
arthritis, psoriatic arthritis and ankylosing spondylitis. Simponi
requires only monthly injections, compared to higher frequencies for
existing meds."
Thanks for posting this Suzanne.
I think this drug is being considered for approval by the US, will have to watch for it, it may be an alternative for some to consider.
[QUOTE=Joie]I think this drug is being considered for approval by the US, will have to watch for it, it may be an alternative for some to consider.
[/QUOTE]
From the link:
"This marks the first approval for Simponi, which is still awaiting a
decision from the FDA. J&J will market the drug in the U.S., while
Schering-Plough will be responsible for Simponi in other markets."Here is another link:
http://www.businessweek.com/ap/financialnews/D97HQMG01.htm
More about the drug cos. than the med - gold star if you can follow the last two paragraphs! J&J, Shering-Plough, Centocor.......
Interesting post.
SAN FRANCISCO, June 29 -- Golimumab (Simponi) alleviates rheumatoid arthritis symptoms in patients who have previously received another tumor necrosis factor-alpha inhibitor, researchers found.
Golimumab more than doubled the number of RA patients who had at least a 20% improvement in signs and symptoms, compared with placebo (35% to 38% versus 18%, P=0.0006 to P=0.0001), Josef S. Smolen, MD, of the Medical University of Vienna and Hietzing Hospital in Vienna, and colleagues reported.
Although there have been some concerns about safety with tumor necrosis factor (TNF)-alpha inhibitors, this randomized clinical trial revealed no major short-term safety concerns, they wrote online in The Lancet.
In April, golimumab became the fifth biologic agent the FDA has approved for rheumatoid arthritis, joining etanercept (Enbrel), infliximab (Remicade), adalimumab (Humira), and abatacept (Orencia).
"Do we really need another TNF-alpha inhibitor? As long as no available drug is effective in all patients, the answer would seem to be 'yes,' " said Yusuf Yazici, MD, of New York University Hospital for Joint Diseases in New York.