U.S FDA getting to the heart of GlaxoSmithKline plc (NYSE:GSK)’ Avandia matter.

by Tom Kelly | Saturday, Apr 13, 2013 | 453 views

Northern, WI 04/13/2013 (usastockreport) – GlaxoSmithKline plc (NYSE:GSK) (Closed: $48.47, Down by 0.10%)’s best-selling diabetes pill, Avandia had been taken off the European market and is under very tight restrictions in the United States due to the heart risks its poses. The U.S Food drug Administration will be reviewing it again. The Record or study of Avandia that had been conducted in 2009 had revealed that the drug more than doubles heart failure risk. Neither was there an increase in hospital stays nor any death reported due to cardiovascular disease. The meeting is scheduled to be held in June. A previous advisory panel had requested the re-analysis as they had found that the drug should continue to be available in the United States.

Standing-by its product

In a telephone interview, a spokesperson for the London-based drug maker said that no new applications will be filed by Glaxo for Avandia.  The company isn’t seeking a wider use of the drug either. She said that a journal will be publishing the results and its summary has been posted on the clinical trial register of the company. The company welcomes the opportunity to put forward the update before the Food and Drug Administration with reference to the completion of the post marketing requirements that are related to Avandia. Glaxo stands firmly behind the efficacy and safety of Avandia when it is used in accordance with the instructions on the label and in an appropriate manner.

Restricted sale

Analysts who track the FDA have said that that the decision to review the data further is an unusual one and may be an indication that the FDA wants to try to pull out the drug again. At one point of time, Avandia had annual sales of $3 billion but had posted a $19 million loss last year. The agency might have something that will give them leverage in this new adjunction. Today, the drug is available to very few people and a two-day advisory committee may be nothing more than a waste of time said the analysts.

An agency spokesperson Morgan Liscinsky said Duke’s reassessment results are being evaluated by the FDA and there is a possibility that they may change the manner in which Avandia is handled at the moment. She said that the agency had been concerned about the original design and follow-through of the study and the review was a result of this concern.

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