Please ensure Javascript is enabled for purposes of website accessibility

For the RECORD ...

By Brian Orelli, PhD – Updated Apr 6, 2017 at 12:56AM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

… Avandia's not going to make a comeback for GlaxoSmithKline.

Sorry, investors, but GlaxoSmithKline's (NYSE:GSK) Avandia isn't going to make a comeback.

It's not that Glaxo isn't trying. The company ran a large, 4,447-patient trial -- dubbed RECORD -- that it hoped would refute a 2007 meta-analysis by Dr. Steven Nissen, which suggested that Avandia increased the risk of heart attacks by 43%. According to results of the trial presented at the American Diabetes Association meeting on Friday, the drug doesn't increase the cardiovascular risk compared to other diabetes drugs. 

But the damage is already done:

 

2006

2007

2008

Sales of Avandia-containing products (in millions)

$3,043

$2,438

$1,489

Year-over-year increase/(decrease)

26%

(20%)

(39%)

There are a couple of reasons why the Avandia franchise will never get back to its $3 billion-a-year heyday. First, while Glaxo will try to get the new positive data on the U.S. label, it's going to take time to negotiate with the Food and Drug Administration.

Second, critics are already poking holes in the study, including the fact that 40% of subjects weren't taking Avandia at the end of the study. It remains to be seen whether that'll create problems for Glaxo's attempts to get the label changed.

But more importantly, there are plenty of other diabetes drugs on the market. If Avandia was the only drug available, doctors would probably shrug off Nissen's findings and start prescribing Avandia again. But with drugs like Merck's (NYSE:MRK) Januvia, Takeda's Actos, and Byetta from Amylin Pharmaceuticals (NASDAQ:AMLN) and Eli Lilly (NYSE: LLY) available, there's not much reason to head back to Avandia in droves. Plus, there's potential for the FDA to approve other diabetes drugs from Novo Nordisk (NYSE:NVO), AstraZeneca (NYSE:AZN), and Bristol-Myers Squibb (NYSE:BMY) in the near future.

Fortunately, Glaxo is large enough to take the hit. Sales of Avandia-containing products were less than 3% of revenue in the first quarter. The new data might be able to stop the bleeding a little, but I feel safe going on the record saying that it's not going to help Avandia make a comeback.

For the record:

Novo Nordisk is a Motley Fool Global Gains recommendation. Investing internationally doesn't have to be scary, and it can certainly be profitable. Click here to grab a free 30-day trial subscription to the newsletter, where you'll see all of our current picks for a global economy. 

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

GSK Stock Quote
GSK
GSK
$28.82 (-1.84%) $0.54
Merck & Co., Inc. Stock Quote
Merck & Co., Inc.
MRK
$86.18 (-0.69%) $0.60
Eli Lilly and Company Stock Quote
Eli Lilly and Company
LLY
$307.50 (-1.27%) $-3.96
AstraZeneca PLC Stock Quote
AstraZeneca PLC
AZN
$53.02 (-2.86%) $-1.56
Bristol Myers Squibb Company Stock Quote
Bristol Myers Squibb Company
BMY
$70.15 (-0.79%) $0.56
Novo Nordisk A/S Stock Quote
Novo Nordisk A/S
NVO
$95.28 (-2.71%) $-2.65

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
329%
 
S&P 500 Returns
106%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 09/27/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.