Glaxo Angers the FDA

Every large-cap pharma seems to have at least one marketed drug that produces endless streams of woe for them. In GlaxoSmithKline's (NYSE: GSK  ) case, the drug in question is its type 2 diabetes compound, Avandia. Yesterday, Glaxo announced that the FDA had sent it a warning letter regarding its failure to meet certain post-marketing requirements for Avandia.

Since last year, when a meta-analysis came out in the "New England Journal of Medicine" that showed Avandia may be associated with an increase in cardiovascular-related adverse events, sales of the drug have taken a nosedive. In its 2007 fourth-quarter financial report, for instance, worldwide sales of Avandia, and Glaxo's combo drugs with Avandia, were down 43% year over year, to $472 million.

The FDA had expected Glaxo to report periodically on the results and progress of all post-marketing safety studies for Avandia. European Union medical authorities requested safety studies of their own for Avandia, and Glaxo failed to report the status of these studies to the FDA.

Glaxo thought that because these studies were initiated at the behest of the European Medicines Agency, it didn't have to report them. The FDA argued it didn't matter who requested the additional studies and, because they were related to the drug's safety, they fell under the agency's mandatory post-marketing reporting requirements for Avandia.

Is all this a big deal? Possibly. The FDA did sound annoyed in the warning letter to Glaxo. The agency requested that Glaxo review its post-marketing reporting for every single one of its approved therapies, and until its post-marketing reporting violations are corrected, "any pending [drug marketing applications] submitted by [GlaxoSmithKline] may not be approved."

That part about potential delays with compounds awaiting approval is why shares of POZEN (Nasdaq: POZN  ) were down yesterday. It is awaiting an FDA review on its migraine drug that is partnered with Glaxo and has an FDA decision expected in the middle of this month.

One has to wonder what possible effects the FDA's warning could have on other Glaxo-partnered compounds under review, like Adolor's (Nasdaq: ADLR  ) potential post-operative ileus compound, Entereg. Glaxo was responsible for a good chunk of that drug's development. Neither of these compounds' marketing applications is in Glaxo's name, so perhaps any FDA anger at Glaxo will have little collateral damage.

Read/Post Comments (0) | Recommend This Article (3)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 618699, ~/Articles/ArticleHandler.aspx, 10/24/2016 10:30:17 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated Moments ago Sponsored by:
DOW 18,224.84 79.13 0.44%
S&P 500 2,151.13 9.97 0.47%
NASD 5,302.01 44.61 0.85%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

10/24/2016 10:14 AM
GSK $40.84 Down -0.29 -0.71%
GlaxoSmithKline CAPS Rating: ***
ADLR.DL $4.77 Down +0.00 +0.00%
Adolor Corp CAPS Rating: *
ARLZ $4.82 Down -0.11 -2.23%
Aralez Pharmaceuti… CAPS Rating: **