Thursday, September 23, 2010

Gilenya approved. Now what?

So the FDA has approved a pill for MS, Gilenya (nee fingolimod). Now all we need is some data that tells us which of the available disease-modifying drugs might work better. Until somebody starts to generate comparative data, choosing a DMD for MS will be like choosing which brand of cigarettes to smoke: "Yeah, I like that Avonex is cheaper, but it's really a woman's brand. Rebif seems to work OK, but only black people shoot Rebif. Me, I'm more of a rugged, outdoorsey Copaxone guy."

If you want to reduce the cost of providing care for chronic conditions like MS, you should probably start by figuring out whether some drugs work better than others. If it turns out that some work better than others, create an incentive for using the drugs that work best. If they're all equally effective, create an incentive for using the drugs that are cheaper.


Kim said...

I'm in the clinical trial for Gilenya vs. Avonex. They did this trial in tandem with the other broader ones with placebo only. The results show that Gilenya is significantly better than Avonex. I believe I last saw it being 52% more effective than Avonex at holding off relaspes. The trial was called Transforms fty720 if you want to search on it.
Here's one posting:

Anonymous said...

In addition to the clinical trial of Gileyna vs. Avonex, several or the clinical trial patients had tried other injectables before. Gileyna showed efficacy in all instances, which in itself is significant. Most importantly, however, Gileyna is not simply an injectable in a pill form --the reason that the FDA approval took somewhat longer is that it is an entirely new approach, repairing the myelin sheaths, and has actually reduced MS spots. For that reason, there is now a clinical trial being conducted for using it for PPMS, which if successful would the first medication for that form of MS. This medication is not simply old wine in new bottles, despite your apparent cleverness of comparing it to one more brand of cigarettes.

Doug Lee-Knowles said...

Anon, I know Gilenya's new wine, but a comparison to Avonex doesn't seem very helpful. My recollection is that at least one head-to-head trial (INCOMIN? EVIDENCE?) suggested Avonex is the least effective of the interferons for RRMS. How does Gilenya compare to Rebif or Copaxone? I'm not a scientist, but it doesn't seem very significant that the Gilenya trial included patients who'd tried the injectable disease-modifying drugs.

Doug Lee-Knowles said...

And I think Anon might be wrong about Gilenya "repairing the myelin sheaths, and has actually reduced MS spots."

From Gilenya's prescribing information:

12.1 Mechanism of Action
Fingolimod is metabolized by phingosine kinase to the active metabolite, fingolimod-phosphate. Fingolimod-phosphate is a sphingosine 1-phosphate receptor modulator, and binds with high affinity to sphingosine 1-phosphate receptors 1, 3, 4, and 5. Fingolimod-phosphate blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which fingolimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system.

Sounds more like it's aimed at the blood/brain barrier...