Datamonitor: GSK's Avandia is dead in Europe, and as good as in the US

Oct. 15, 2010 - PRLog -- Datamonitor expects DPP-4 inhibitors, led by Merck's blockbuster drug Januvia, to increase their market share, based on their benign safety profile.

Sales of GlaxoSmithKline's anti-diabetic Avandia (rosiglitazone) will be halted in Europe, after the EMA's Committee for Medicinal Products for Human Use recommended that its marketing authorizations be suspended, on the basis that "the benefits of rosiglitazone no longer outweigh its risks". Meanwhile, in the US, although the FDA has not withdrawn Avandia's marketing authorization completely, it has restricted its use, imposing increased risk communication requirements and mandating that patients be either current users, or be unable to achieve blood sugar control on other medications.

Avandia recorded global sales of $491m in the first half of 2010, with the majority of its revenue coming from the US and Europe. Since the 2007 publication of a meta-analysis by cardiologist Dr Steve Nissen that showed that Avandia may increase the risk of heart attacks and other cardiovascular events, sales of the franchise, worth $3.2 billion in 2006, have fallen steadily, even though the risk continued to be debated.

Datamonitor believes that sales of Avandia in the US will plummet, as existing patients are likely to switch medications and new patients will not be prescribed the therapy. In Europe, sales are expected to drop rapidly to zero over the next few months. GlaxoSmithKline has also announced that it will stop promoting Avandia products in all of its markets.

The difference between European and American recommendations will therefore have little effect on Avandia sales. European marketing authorizations are only temporary, and can be suspended easily on the advice of the EMA. In contrast, the FDA does not generally have the power to suspend sales once a drug is approved. In addition, in July 2010, an FDA advisory panel majority recommended against the complete withdrawal of Avandia (20-12). However, most of the panel did support some form of increased restriction or warning, advice that the FDA has followed.

The moves by the EMA and the FDA demonstrate an increased emphasis on safety from the regulators. The FDA has already imposed cardiovascular safety requirements on future diabetes drugs, and Datamonitor predicts that for pipeline drugs looking to enter the crowded diabetes market, simply showing an effect on blood sugar levels will increasingly be seen as insufficient without evidence of an effect on other cardiovascular outcomes, such as lower blood pressure or weight loss. Cardiovascular events are the leading cause of death for type 2 diabetics, therefore it is important for diabetes drugs not to increase this risk.

Avandia's reduced sales will lead to gains for the class-leading Actos franchise (pioglitazone) from Takeda, as patients switch within the glitazone class. However, Actos itself has become the subject of an FDA safety review into a possible link between the drug and bladder cancer. Furthermore, Actos will lose patent protection in January 2011, and cheap generic pioglitazone will take sales from the branded product; therefore, Takeda will only have a brief opportunity to capitalize on this new blow to its competitor.

Datamonitor forecasts that the anti-diabetic DPP-4 inhibitor class, led by Merck's blockbuster Januvia (sitagliptin), will gain sales from Avandia's sales restrictions. DPP-4 inhibitors are less effective than Avandia and Actos at lowering blood sugar, but they have a better safety profile, making them more attractive in the current environment. The fall of the glitazone brands also represents an opportunity for newer drug classes to seize market share. As the diabetic population continues to grow, Datamonitor predicts that the diabetes market will remain an attractive commercial target. Its 2010-19 forecast of the market is currently being updated to show the impact of the drastic reduction in Avandia sales in the US and Europe.  

Related research

Datamonitor: Stakeholder Opinions: Cardiovascular and Metabolic Generics - Generics continue to gain prominence:
http://www.reports-research.com/market-surveys/stakeholde...

Datamonitor: Stakeholder Opinions: Fixed dose combinations in the cardiovascular and metabolic diseases - From life cycle management to franchise:
http://www.reports-research.com/market-surveys/stakeholde...

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