FDA slaps cardiovascular warnings on Roche/Novartis asthma blockbuster Xolair

It was way back in 2009 when the FDA first indicated it was worried about reports of heart attacks and strokes in patients taking Xolair, the asthma treatment co-marketed by Novartis ($NVS) and Roche ($RHHBY). Now the agency is taking action, slapping new warnings to the product's label confirming that it's associated with cardiovascular risks.

The warnings will not be contained in a prominent "black box" on Xolair's packaging but rather in the "Adverse Reactions" section of its label, according to an announcement from the FDA. That's the good news.

The bad news is that the warnings are somewhat scary. The FDA reviewed data from a 5-year study, along with 25 trials comparing Xolair to placebo, and determined that the drug raises the risk of problems occurring in the blood vessels of the heart and brain, including clots, heart attacks, mini-strokes, chest pain and pulmonary hypertension--high blood pressure in the lungs' arteries that can be life-threatening. Due to weaknesses in how the 5-year study was designed, however, the FDA is unable to determine exactly how big the risks are, the FDA says.

Roche and Novartis say they worked closely with the FDA on the updates. In a statement acquired by Reuters, the companies added that they were committed to patient safety and they believe "the revisions will provide healthcare professionals and their patients with the most up-to-date information to make informed healthcare decisions."

The FDA approved Xolair in 2003 to be used in patients whose asthma was not well controlled by commonly used steroid inhalers. But the drug has been a major success nonetheless, generating total sales of $1.5 billion for Roche and Novartis last year.

Xolair is poised for even more growth, thanks to European and U.S. approvals this year for the treatment of chronic idiopathic urticaria, a skin condition marked by chronic hives. The approvals prompted Novartis to predict its dermatology division would eventually be hauling in $2 billion in annual sales, not just from Xolair, but also from the company's psoriasis treatment secukinumab, which is currently awaiting FDA approval. The agency has scheduled an advisory committee meeting to discuss the psoriasis drug on October 20.

As for Roche, it's looking to bolster Xolair with the next generation of asthma fighters. In March, the company trumpeted positive Phase IIb data for lebrikizumab, an IL-13 antibody that targets a cytokine believed to trigger severe asthma. CEO Severin Schwan has pegged the drug as one of three big blockbusters in Roche's pipeline and expects it to start making its way to regulators in 2016.

- here's the FDA's announcement
- read more at Reuters

Special Report: Top 10 pharma companies by 2013 revenue - Novartis - Roche

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