This is interesting, and a bit concerning. One of the parents in an infantile spasms support group on Facebook that Stacy is a part of posted a link to a press release about the FDA approving ACTH for infantile spasms. The press release can be found here:
I think this is a good thing, but my concern lies in the fact that James started ACTH treatment for his infantile spasms back in February…8 months before the FDA approved it. I don’t remember the manufacturer of the ACTH that James was taking so I suppose it is possible that James was taking an ACTH treatment by a manufacturer that was approved by the FDA. The announcement in the press release above is specifically for Questcor Pharmaceuticals’ ACTH treatment.
But what if James was on Questcor’s ACTH treatment? Are they allowed to prescribe drugs and treatments that aren’t approved by the FDA? That is a bit scary.
What also concerns me about the FDA approval for Questcor’s ACTH is that “the FDA has also granted Acthar a seven-year exclusivity period during which the FDA is prohibited from approving any other adrenocorticotropic hormone (ACTH) formulation for IS unless the other formulation is demonstrated to be clinically superior to Acthar.” Does this mean that Questcor could possibly have the only FDA approved ACTH treatment for the next 7 years? When James started ACTH in February, the cost of the treatment was $74,000. If Questcor has the only FDA approved ACTH treatment for the next seven years, I have a feeling it is going to get a lot more expensive than that!
Unfortunately, the ACTH did not work for James. We are still trying to find something that works. Sabril has shown some improvements in his infantile spasms, but they are not gone yet.