Good News: The FDA have "approved" the oral diabetes/obesity drug Pargluva (muraglitazar). The drug could be the "first in class" of dual peroxisome proliferators-activator receptor agonists, or PPAR agonists launched.
Bad News: The FDA want more data to confirm it doesn't increase the chance of heart attacks (a message from the FDA for Merck, there, Insider wonders). This will delay any US launch by at least a year, possibly even two.
Sounds reasonable to Insider, given the current chilly regulatory climate. In addition to the MI concerns adverse effects seen with some dual-acting PPAR agonists in advanced-stage development have included oedema, raised levels of hepatic enzymes and tumours in rodents.
It may also be good news for AZs' Galida, which might be able to catch up a little.
Sources: The Street.
http://www.diabetesincontrol.com/modules.php?name=News&file=article&sid=2851
http://www.drugdevelopment-technology.com/projects/galida/
Update:
Uh oh! Looking "difficult" for Pargluva:
http://jama.ama-assn.org/cgi/content/full/294.20.joc50147v1
5 comments:
Yep, MK-767 (the failed glitazar diabetic drug) was withdrawn in late phase III because it was causing tumors in rodents.
Has anyone really looked into whether evidence existed earlier that this was the case?
I'm starting to wonder if the PPAR drugs are ever going to able to live up to the expectation that many people had for them. The whole point of an alpha-gamma combination was to reduce blood sugar and improve cardiovascular health at the same time, which makes the emergence of cardiovascular risk with Pargluva particularly annoying.
That whole nuclear receptor field is still a wonderful area for basic research, but turning things into useful drugs has been harder than anticipated. For a while there, it looked as if we'd be able to take all sorts of combination of the three subtypes and turn out drugs for all sorts of indications - diabetes, high blood lipids, various cancers, wound healing, what have you. And perhaps we still can, after another ten or twenty years of hard labor.
Clearly this information comes from uneducated individuals. Pargluva was not approved! Get your facts straight.
Sorry, 3.47 AM. but you are inconsistent with the actualitee! The "official" line from the two companies is that they received an "approvable letter" from the FDA for Pargluva!
Of course, there was the bad news as well (all that inconvenient safety data they have to get before they can launch it etc etc). Crazy but true! Check their joint press statement.
"FDA Issues Approvable Letter for Investigational Type 2 Diabetes Drug
10/19/2005
The FDA has issued an approvable letter for Bristol-Myers Squibb’s and Merck & Co., Inc.’s for Pargluva (muraglitazar), an investigational oral medicine for the treatment of type 2 diabetes. Additional safety information from ongoing trials or from those completed since the safety data from the last formal regulatory submission has been requested to fully address Pargluva’s cardiovascular safety profile. "
Just thought I'd look it up to be helpful
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