Please login to the form below

Not currently logged in
Email:
Password:

Novo Nordisk wins US approval for haemophilia treatment

NovoEight will be launched alongside MixPro device after gaining FDA licence

Novo Nordisk US HQ 

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.

The product adds to Novo's growing haemophilia business, which also includes NovoThirteen. The drug is recommended in the EU for the long-term prevention of bleeding in adults and children aged six and over who have the inherited blood disorder congenital factor-XIII-A-subunit deficiency.

Article by
Thomas Meek

16th October 2013

From: Sales

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Novasecta

We are a specialist strategy consulting firm for pharmaceutical and biotech companies. We help our clients to achieve significant performance...

Latest intelligence

Navigating the antibiotic resistance crisis
Blue Latitude Health speaks to Tara DeBoer, PhD, Postdoctoral Researcher and CEO of BioAmp Diagnostics to explore the antimicrobial resistance crisis, and learn how a simple tool could support physicians...
Combined immunotherapies – potential and pitfalls
‘Combining therapeutic compounds is the first logical step towards better results, namely higher rates of patients responding to treatment, with deeper and more sustained responses’...
Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...

Infographics