Diabetes Drug Wins Approval, Helps the Competition

diabetesThe approval of Novo Nordisk‘s diabetes drug Victoza has led to an unintended benefit for a competitor. On Tuesday, the Danish company announced that the U.S. Food and Drug Administration approved Victoza (liraglutide) for the treatment of Type 2 diabetes. The news fueled optimism that a similar drug by Amylin Pharmaceuticals will be approved later this year, the Wall Street Journal reports. Shares in Amylin jumped to their highest point in 52 weeks following Novo Nordisk’s announcement.

San Diego-based Amylin plans to launch its once-weekly version of Byetta (exenatide) later this year, the company announced Thursday.  Byetta LAR has the potential to become the first once-weekly treatment for diabetes. The FDA could make a decision on its approval by early March. According to Bloomberg, one analyst estimates that the drug could generate revenue of $1.8 billion in 2013. A twice-daily version of Byetta has been on the market since 2005, but it has not been profitable as of yet. Byetta is a synthetic version of a hormone found in the saliva of the Gila monster. Amylin developed the drug with Eli Lilly and Alkermes.

Both Victoza and Byetta are similar to a gut hormone called GLP-1, which increases the secretion of insulin in response to elevated blood sugar, slows the release of glucagon (a hormone responsible for raising blood sugar levels), and reduces the rate at which food is absorbed into the bloodstream. The FDA has required post-approval safety studies of Victoza following concerns about pancreatitis (a risk also associated with Byetta) and thyroid cancer. In laboratory studies, Victoza caused thyroid tumors in rodents. However, the rodents who developed tumors were given doses eight times higher than a human would receive.  It is unknown whether the drug causes tumors in humans.

In an interview with Luke Timmerman of Xconomy, Amylin CEO Dan Bradbury discussed plans to develop and expand the Byetta LAR product line.  Amylin is working on a pen-injected version of the drug (the current form uses a syringe).  The company is also studying an injectable suspension, a transdermal patch, and a nasal spray.

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