Tesamorelin (Egrifta) is now FDA-approved!

Thank goodness for good friends & colleagues like Dr. C who asked me about tesamorelin today.  I'd been following this growth hormone releasing factor analog for a while as it wended its way thru FDA Phase I thru III trials in HIV-positive patients.  I even remember discussing its implications back in May 2010 when it went before the FDA.  Well, then everything went to h-ll in a hand basket as my employment status became murky to say the least.  So from August to November, I really didn't peruse the literature as I usually try to do since I no longer had an outlet to post my thoughts.  Of course, that's when the FDA approved the use of tesamorelin (Egrifta) for lipodystrophy in HIV-positive patients.  Boy, did I ever miss the boat on this - I'm 3 months late!  So I'm eternally grateful to Dr. C for keeping me on my toes.

So what good is tesamorelin?  Up until this past November, we'd been restricted (and still are) from using recombinant human growth hormone off-label.  Of course, this is all very political because traditionally, physicians have been given free-rein to use any and all other medications off-label once they're approved for at least one indication by the FDA.  For those physician playing by the rules, you had to subject your patient to growth hormone stimulating tests, one of which could be a risky session involving insulin leading to hypoglycemia.

Well, we now have an agent that can be used off-label to increase growth hormone release and thus measurable insulin-like growth factor-1 without the requirement for undergoing invasive & risky stimulation testing.  I must admit to surprise that this medication came out without much fanfare, at least in the anti-aging and age management medicine arena as I attended two major meetings this past winter w/o mention of this medication.  And having just perused the Internet, I didn't find much celebration & elation.

In any case, don't be surprised if your anti-aging or age management physician starts recommending Egrifta to increase your IGF-1.  Just be aware that we still don't have long term (safety) data.  Plus, there's always the cost issue.  Stay tuned!