A study published this year linking the GLP-1 class of drugs for Type 2 diabetes to an increased risk of pancreatic cancer sent a shock wave through the industry. Regulators in the U.S. and Europe decided to take a deep dive into the issue and their findings will have big implications for these drugs, some of which hold blockbuster status. The FDA has yet to announce its finding, but the European Medicines Agency (EMA) today said the data just are not substantial enough to make the connection.
"Available data do not confirm recent concerns over an increased risk of pancreatic adverse events with these medicines," the EMA's Committee for Medicinal Products for Human Use (CHMP) said in a statement. The EMA consulted experts and decided that "the study itself had a number of methodological limitations and potential sources of bias." It said the companies that make the drugs are continuing to watch closely for risks. Researchers analyzed insurance records to find that patients hospitalized with pancreatitis were twice as likely to be using Merck's ($MRK) Januvia or Bristol-Myers Squibb's ($BMY) Byetta, when compared with diabetics who didn't have pancreatitis. Pancreatitis can lead to pancreatic cancer.
Drugs that effectively fight Type 2 diabetes have become hot-ticket items in the face of an upsurge in the disease globally. Among those in the GLP-1-class of drugs under review are big names like Byetta, Victoza from Novo Nordisk ($NVO), which brought in $1.7 billion last year, and Januvia, which tops the class in sales with $4 billion last year.
Drugmakers are still holding their breath to see what the FDA finds. In 2007 the agency flagged pancreatitis cases in Byetta patients and then amped up the warnings in 2008 when Byetta was tied to 6 deaths in patients who had developed pancreatitis, though four of them couldn't be causally linked to the condition. A year later, it did the same for labels on Januvia.
The review comes in the shadow of the FDA's decision last month concerning GlaxoSmithKline's ($GSK) Avandia, a diabetes drug that was pulled from the market in Europe and regulated into near irrelevance in the U.S. before the agency decided to revisit its cardiovascular risks this year. A divided panel of experts last month recommended that the agency ease restrictions on the drug.
- here's the EMA statement
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