Novo Nordisk settles claims related to Victoza marketing
- Novo Nordisk revealed Tuesday it will pay out $46.5 million to federal and state governments in order to settle claims related to its blockbuster Victoza.
- The claims tie back to allegations the Danish drugmaker did not fully comply with the safety information in the Food and Drug Administration-approved Risk Evaluation and Mitigation Strategy (REMS) program.
- Novo will also pay another $12.15 million to resolve a complaint filed by the government on behalf of the FDA in federal court.
The suit, originally filed in February 2011, focused on the marketing of Novo's type 2 diabetes Victoza (liraglutide). The GLP antagonist is the Danish drugmaker’s best-selling drug with sales of 11.53 billion Danish kroner ($1.7 billion) during the first half of 2017.
The government alleged that after approval of Victoza in 2010, Novo Nordisk failed to comply with the Federal Food, Drug, and Cosmetic Act from 2010 to 2012.
A REMS program put in place at the time of Victoza’s approval requires the company inform doctors of the potential risk for patients to develop a rare cancer called medullary thyroid carcinoma (MTC).
"As alleged in the complaint, some Novo Nordisk sales representatives gave information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant," wrote the U.S. Department of Justice in a statement.
"The complaint further alleges that Novo Nordisk failed to comply with the REMS by creating the false or misleading impression about the Victoza REMS-required risk message that violated provisions of the FDCA and led some physicians to be unaware of the potential risks when prescribing Victoza."
The Justice Department goes on to claim a 2011 survey showed physicians were unaware of the risk and that instead of helping to increase awareness, the company further obscured risk information through efforts from sales reps.
"Our focus will always be to ensure that those caring for patients have the data they need to make the most informed treatment decision," said Doug Langa, EVP and head of North America Operations and president of Novo Nordisk Inc.
"While we do not agree with the U.S. government's legal conclusions and deny any wrongdoing, we're pleased to have negotiated a resolution that allows the company to return its full attention to developing medicines that help improve the lives of patients."
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