More Bad News For Avandia
As if GlaxoSmithKline (NYSE:GSK) doesn’t have enough problems with Avandia a new analysis of the drug by German researchers found little evidence that the drug improved the quality of diabetics’ lives and concluded it could actually worsen complications of the disease. Published in the Cochrane Library journal, the study pooled data from 18 past trials involving 8,000 patients.
Dr. Bernd Richter of Duesseldorf’s Heinrich-Heine University, who led the research, stated “I see a bundle of adverse events, and I don’t see really good positive effects.” Dr. Richter also questioned whether it was ethical to conduct any further trials with Avandia, since “less dangerous” alternatives were available. According to Dr. Richter his research was conducted independently of the meta-analysis by Dr. Steven Nissen, which started the Avandia controversy.
Not unexpectedly Glaxo is standing by Avandia and is dismissing Dr. Richter’s conclusions.
Now that two researchers have independently reached the same conclusions on Avandia the July 30th FDA panel is setting up as one of the biggest events in the diabetes market.
According to the FDA the panel will consist of the available members of the standing committees along with others added by the review division to supplement the expertise needed for the meeting discussion. You can go to http://www.fda.gov/cder/audiences/acspage/endocrineroster1.htm and http://www.fda.gov/cder/audiences/acspage/dsarmroster.htm for a list of Endocrinologic and Metabolic Drugs Advisory Committee Roster and Drug Safety and Risk Management Advisory Committee Roster. A draft list of all panel members is scheduled to be available next Friday July 27th.
With Avandia prescriptions falling into a black hole and a growing body of evidence against the drug it’s difficult to imagine a scenario where Glaxo can save the drug. The more intriguing question is what the panel will say in regards to Actos. Although the panel was called because of the Avandia controversy they will look at all thiazolidinediones. The FDA is not requiring Takeda, the makers of Actos, to testify which leads one to believe they are more concerned with Avandia. So far there have no published studies that indicate that Actos carries the same risk as Avandia, although the drug is not free from side effects.
Complicating matters for patients and physicians are recent study’s that question the effectiveness of newer oral therapies.
Just how all this plays out is anyone’s guess. Diabetic Investor believes the possibility that Glaxo will pull Avandia from the market has increased and the panel meeting could be the straw that breaks the camels back. Although we have yet to see any evidence that Actos carries the same risk as Avandia, physicians could well decide that if Avandia is pulled from the market to abandon Actos – guilt by association. This leaves Januvia from Merck (NYSE:MRK) as the primary winner although as we reported yesterday Januvia’s results have been far from impressive.
Should Avandia and Actos go bye bye, treatment options for type 2 patients narrows to Januvia, Byetta from Amylin (NASDAQ:AMLN), metformin, sulfonylureas and insulin. Even with Actos in the mix physicians will be forced to reexamine their treatment regimens.
Although the Street seems unwilling to accept it, injectable drugs like Byetta and insulin, will see increased usage by default. The bottom line here is things are lining up very nicely for Amylin and Novo Nordisk (NYSE:NVO). With the long acting once a week version of Byetta progressing nicely Diabetic Investor sees Amylin in the catbirds seat. Novo also has a GLP-1 under development but is stronger in the insulin arena where they not only have a solid product portfolio but the best delivery devices in the business. These are two solid companies investors should not ignore.