US regulators have approved NovoEight, Novo Nordisk’s new treatment for people with haemophilia A.
The drug will be used in conjunction with Novo’s MixPro, the pre-filled device that was launched earlier this year and is already in use with the company’s NovoSeven treatment for bleeding episodes in haemophilia A or B patients with inhibitors.
An estimated 350,000 people worldwide have haemophilia A, although the condition is thought to be severely under-diagnosed in developing countries. Those affected are either missing or have a malfunctioning factor VIII protein, a factor in blood clotting.
Despite the approval, Novo does not intend to launch NovoEight in the US until April 2015, stating that is “awaiting the expiration of existing patents”.
Novo did not clarify what these patents were, but spokesperson confirmed they were “third-party patents”.
Novo’s existing haemophilia A and B treatment for patients with inhibitors, NovoSeven, began to lose its protection in the US in 2011.
Despite this, the drug still pulled in $1.4bn in revenues in 2012, although Novo expects this to fall over the next few years.
The US approval follows a positive recommendation for NovoEight from the European Medicines Agency (EMA) made last month.
Novo said it expects to launch the drug in Europe in early 2014, where it will compete with established products, such as Baxter’s Advate, Bayer’s Kogenate and Pfizer’s ReFacto.