Regulatory Affairs

Novo Nordisk settles US suit over diabetes drug Victoza

PBR Staff Writer Published 07 September 2017

Novo Nordisk has agreed to pay $58.65m to settle charges relating to the marketing of its type 2 diabetes drug Victoza (liraglutide) in the US.

The settlement with the US federal government is for resolving claims that the Danish multinational pharma failed to comply with the US Food and Drug Administration (FDA)-mandated Risk Evaluation and Mitigation Strategy (REMS) for the diabetes medication.

An investigation into the charges was initiated in February 2011 pertaining to the sales and marketing practices of the Novo Nordisk diabetes drug.

Justice Department Civil Division Acting Assistant Attorney General Chad A. Readler said: “Today’s resolution demonstrates the Department of Justice’s continued commitment to ensuring that drug manufacturers comply with the law.

“When a drug manufacturer fails to share accurate risk information with doctors and patients, it deprives physicians of information vital to medical decision-making.”

As per the terms of the settlement agreement, Novo Nordisk will compensate nearly $46.5m to the US government and to states that reimbursed for the type 2 diabetes medication under their Medicaid programs.

Apart from that, the Danish pharma will pay $12.15m to resolve a complaint filed by the government on FDA’s behalf in federal court.

Novo Nordisk has also resolved seven private whistle-blower cases related to the investigation by the US government into the sales and marketing practices of Victoza.

Novo Nordisk president and North America operations executive vice president, head Doug Langa said: “At Novo Nordisk, we take our responsibility to communicate the safety and clinical benefits of our medicines seriously, and remain committed to properly addressing safety questions healthcare professionals ask every day.

“Our focus will always be to ensure that those caring for patients have the data they need to make the most informed treatment decision.”

Langa concluded that the company does not agree with the legal conclusions of the US government but pleased to return its full focus to developing medicines having negotiated a resolution.