Fda Notes Heart Events, Tumors With Novo Drug
Results from the Danish drugmaker show that liraglutide helped control blood sugar when used alone or with other medications. But regulators have concerns about a small number of heart problems seen in patients as well as thyroid tumors when the drug was tested on rats and mice.
Shares of Novo Nordisk fell $2.39, or 4.8 percent, to $47.72 in morning trading.
The company is hoping its once-a-day injection can take sales away from Byetta, a twice-a-day injection from Eli Lilly and Amylin Pharmaceuticals that has a similar formulation.
The FDA meets with its outside diabetes experts this week to review liraglutide and another drug looking to compete in the $5.1 billion U.S. market for diabetes drugs, which is growing as the disease becomes more prevalent.
The FDA has begun demanding more rigorous safety testing of diabetes drugs since a 2007 analysis suggested GlaxoSmithKlines blockbuster pill Avandia could increase heart risks. In December the agency issued new guidelines for testing potential heart problems with diabetes drugs.
The two-day meeting on Wednesday and Thursday should provide insight into FDAs new safety stance, which will affect a slew of treatments headed for the market.
Because Novo Nordisk tested its drug before the FDA issued its guidelines, “full data were not available to permit meaningful assessment” of heart risks, the FDA noted.
When the company analyzed its data, rates of heart attack, stroke and other problems with liraglutide were similar to those of drugs already on the market. But when the drug was compared against placebo, its risks were sometimes above thresholds set by the FDA.
The agency will ask its panel Thursday whether the companys drug appears safe compared with older drugs.
Regulators also will raise concerns about cancerous thyroid tumors seen in rats and mice injected with liraglutide over two years. In its application, Novo Nordisk argued those results dont necessarily apply to humans, but FDA reviewers are not sure.
“The weight of … clinical data is not sufficient to conclude liraglutide-indiced thyroid-cell tumors are rodent-specific,” reviewers stated in documents posted online Tuesday.
Panelists will weigh in on whether the drug should be approved. The FDA is not required to follow the advice of its panels, though it usually does.
Liraglutide belongs to the GLP-1 family of diabetes medications, which also includes Byetta. Both drugs help control blood sugar by increasing insulin production, slowing the bodys absorption of sugar.
Novos drug would enjoy an advantage over Byetta because it requires one injection per day, instead of two.
But Byetta developers – Eli Lilly, Amylin Pharmaceuticals and partner Alkermes Inc. – plan to launch a long-acting version of the drug that would require just one weekly injection. On Tuesday the drugmakers said that drug, called exenatide LAR, was more effective than competing medications from Merck & Co. and Takeda Pharmaceutical Co. in a head-to-head trial.
Shares of San Diego-based Amylin gained $1.93, or 17 percent, to reach $13.25 in morning trading.