Subcutaneous (SQ) Administration of Omontys is safe and effective
There is no good clinical reason to administer Omontys intravenously. All Affymax has to do is reintroduce it for subcutaneous (SQ) administration only. According to the recall news, there were no hypersensitivity reactions or deaths reported with subcutaneous administration. IN addition, Amgen's ESAs (Epogen & Aranesp) have the same hypersensitivity warnings as Affymax's Omontys. Actually the SQ adminstration is better and probably more effective for dialysis patients. I invested heavily in the stock today because my expertise as a pharmacist tells me that elimination of the intravenous administration will not have any significant adverse impact on the use and future growth of the drug. In my opinion Omontys is a major advance in the ESA therapy and once a motnh SQ administration presents many advantages over the three times a week Epogen administration.
This is true. They will call for the relinquishment of IV admin. They did the same thing with Vancomycin when it came out. They at first would allow IV push, but they realized that IV push did not catch a hypersensitivity (which kills by kidney failure). So...you never see it IV push now and only IV/Oral route. This helps catch hypersensitivity. It can kill via IV push...hell any drug can if the person is personally sensitive. Different route is the way to go, which means the drug will be back on the market. I am not worried in the least.
jswong, how do you know if the 3 that passed would have anyway based on their health alone? These people are sick. Hopefully they can figure out what the problem is, come up with a resolution, and earn good graces again.
Because there is no evidence or reports that the SQ administration of the drug in all the patients that received it via the SQ route resulted in any type of hypersensitivity reaction. The reactions are only linked to the intravenous route.