U.S. clearance follows less than a week after Japan approved the therapy.
FDA sanctioned Novo Nordisk’s type 2 diabetes drug Victoza® (liraglutide) as a monotherapy in second-line treatment and in combination with other commonly prescribed oral diabetes therapeutics. U.S. approval comes less than a week after Japanese regulatory authorities gave Victoza the go-ahead.
U.S. approval of Victoza came with a Risk Evaluation and Mitigation Strategy consisting of a medication guide and a communication plan. Novo Nordisk aims to introduce the drug in the U.S. within weeks.
Victoza is a once-daily human GLP-1 (glucagon-like peptide-1) analogue and is given as an injection. “This is the first direct competition to the Byetta franchise,” according to Canaccord Adams life sciences analyst Adam Cutler. Amylin Pharmaceuticals’ Byetta and Victoza belong to the same family of drugs. “Byetta sales and prescription trends have remained flat, and we expect this news to further weaken them.” Byetta brought in $503.9 million through U.S. sales during the first three quarters of last year.
Victoza is intended to help lower blood sugar levels along with diet, exercise, and other selected diabetes medicines. It is not recommended as initial therapy in patients who have not achieved adequate diabetes control on diet and exercise alone.
In five clinical trials involving more than 3,900 people, pancreatitis occurred more often in patients who took Victoza than in patients taking other antidiabetics, the FDA points out. The agency also advices that the therapy should be used with caution in people with a history of pancreatitis and should not be administered to people at risk for medullary thyroid cancer.
Victoza was not associated with an increased risk for cardiovascular events in people who were mainly at low risk for these events. FDA has nonetheless mandated several postmarketing requirements to ensure that Novo Nordisk conducts studies to provide additional information on the safety of this product.
In addition to a cardiovascular safety study in a higher risk population, the company is required to conduct a five-year epidemiological study using a health-claims database to evaluate thyroid and other cancer risks as well as risks for hypoglycemia, pancreatitis, and allergic reactions. To specifically evaluate the risk of medullary thyroid cancer, the company is required to establish a cancer registry to monitor the rate of this type of cancer in the U.S. over the next 15 years.
In animal studies, Victoza caused tumors of the thyroid gland in rats and mice. Some of these tumors were cancers, which were significantly increased in rats who received doses that were eight times higher than what humans would receive. Since it is not known whether Victoza causes thyroid tumors or medullary thyroid cancer, the FDA did not approve Victoza as a first-line therapy.
Novo Nordisk claims that Victoza lowers blood sugar levels by stimulating the release of insulin from beta cells and reducing the release of glucagon from alpha cells when blood sugar levels are high and by slowing gastric emptying. Victoza has also been shown to reduce body weight and body fat mass in people with type 2 diabetes through mechanisms involving reduced hunger and lowered energy intake, the firm states.
Liraglutide is also being developed as an antiobesity agent in nondiabetic patients. Also, earlier this month Novo Nordisk initiated its first Phase I trial with a long-acting oral GLP-1 analogue, Semaglutide, formulated using Emisphere Technologies’ Eligen® Technology.