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Bloomberg reported that pharmaceutical company Novo Nordisk's stock has dropped by 3.3 percent on Oct. 26, making it the company's largest loss in more than a year, after the U.S. Food and Drug Administration (FDA) announced that it may require the Danish drug maker's newest insulin product, Treisba, to undergo additional studies.
The source noted that medications for diabetes, which can be detected with a lab test, have been monitored more closely by health authorities after it was revealed that GlaxoSmithKline's Avandia increased the risk of heart attacks. The FDA also wrote in a report that analyses of previously conducted studies have shown that Novo Nordisk's product poses more of a risk to heart health, compared to the other products on the market
According to Bloomberg, an analyst at Berenberg Bank wrote that if the FDA rules that Novo must conduct additional studies on the cardiovascular effects of Treisba after its initial approval, it could delay the drug reaching the U.S. market by several years.
"There is no cause for concern based on what we know," Mads Krogsgaard Thomsen, Novo's chief science officer told the news source. "This product is approvable. Whether that is with or without a post-approval cardiovascular outcomes study commitment, it's a different story."
Japanese officials have already approved Treisba, as has a European Advisory board on Oct. 19.
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