Anavex Life Sciences Corp (AVXL)

[falconer66a]

From a TGA insider:

...around 75% drugs eventually get approved after SAS, unless there are safety concerns while under SAS.

Thanks for this message, telling that someone inside the Australian Therapeutic Goods Administration (TGA) specifically made this statement.

Consider it.

First, if about three-quarters of drugs in the SAS eventually get approved, what, perchance, would keep the other 25% from being approved? Has to be at least one of two things: inefficacy (the drug doesn't really work), or unsafe (too many or too severe adverse events, side effects).

Efficacy. For Anavex 2-73 in treating Australians with Alzheimer's, in the earliest study, was the drug ineffective; failed to produce positive results? If that were so, why would so many in that study elect to continue to take the drug continuously, for many years, after the formal study was completed? If the drug did not produce real-world results for those in the early trial, there wouldn't have been a near 100% continuance of taking the drug.

Of course, those holding to accepted standards of drug approval studies will claim that data are still insufficient to render a confident positive on blarcamesine against Alzheimer's. "Not enough data to know for sure, yet."

That might be true. But it's not a factor in the recent Special Access Scheme (SAS), allowing Australian physicians now to petition the TGA to prescribe blarcamesine for their patients. Quibble over that as some sort of "approval" as various parties have, or not, the Anavex drug nonetheless will be available to patients, albeit initially for only a few.

Safety. The other, more important reason a drug now in the SAS might not gain eventual full approval would be lack of safety. The drug causes more harm than allowable. It's plainly unsafe, all other factors notwithstanding.

Fortunately, for blarcamesine, that is not a factor of concern. The drug has proven profoundly safe in all of the preclinical murine (lab rodent) tests, and also in all human trials. As noted, side effects of blarcamesine, when they occur, are only a bit of dizziness or headache. Compare those cautionary outcomes to the side effects noted in any of the TV advertisements for prescription drugs on any of the network evening news programs. Many of those, too, are for central nervous system (CNS) diseases. Side effects are severe, some being lethal. Blarcamesine works in the CNS, but has no lethal or other severe side effects. And side effects appear only at maximum doses, or are quickly resolved when dosages are reduced, or after a period of accommodation. The body gets used to the drug.

If these things are true (they are), looks like blarcamesine is highly likely to fall within the 75% of SAS drugs that subsequently get approved.

As with all the clinical blarcamesine data, in both murines and humans, the odds for eventual full approval are now very strong.