Please login to the form below

Not currently logged in
Email:
Password:

Novo Nordisk wins European approval for Refixia

Plans to launch the haemophilia B treatment in the fourth quarter

Novo Nordisk

Novo Nordisk has won EU approval for its new haemophilia drug Reflixia and is planning its first European launches in the fourth quarter.

The European Commission marketing authorisation comes one week after US regulators gave the green light to the drug, which is a long-acting Factor IX treatment for haemophilia B.

Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: "We are excited about the approval of Refixia in the EU, and we consider it an important expansion of the treatment options for patients with haemophilia B.

"The strong clinical profile of Refixia provides haemophilia B patients with better protection against bleeds, even into damaged joints, and an overall improved quality of life."

The half-life of Refixia (nonacog beta pegol or N9-GP) is around five times longer

than standard factor IX products, meaning fewer injections are needed,

Consequently Novo is hoping the new product will help defend its franchise from rival long-acting haemophilia B drug Alprolix (eftrenonacog alfa) from Biogen and Swedish Orphan Biovitrum which was approved in the EU last year.

Article by
Dominic Tyer

7th June 2017

From: Regulatory

Share

Tags

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
integrated medhealth communication

imc group is a leading, independent global healthcare communication group that enables client’s brands to connect with healthcare professionals, payers...

Latest intelligence

Building the hospital of the future
Senior Consultant Leah Carlisle explores the growing trend of virtual hospitals and what it takes to develop a holistic digital ecosystem centered on the ultimate patient experience....
Why people join a clinical trial
To understand why people decide to take part in clinical trials, you first need to understand how people make decisions....
Article:
The disparity of patient experiences with Crohn’s Disease in Europe and Japan...