Please login to the form below

Not currently logged in
Email:
Password:

Novo drops late-stage haemophilia candidate vatreptacog alfa

Patients developed anti-drug antibodies during phase III clinical trial

Novo Nordisk has halted the development of its haemophilia drug vatreptacog alfa after patients developed antibodies to the medicine.

The company dropped vatreptacog alfa, which was intended to stop bleeding in patients with haemophilia and inhibitors, following phase III trial results showing the immune system of several patients had targeted the treatment, including one with a “potentially neutralising effect”.

This trial involved 72 haemophilia patients with an existing inhibitor – an antibody to the product used to treat or prevent bleeding episodes.

These patients were treated on demand with either vatreptacog alfa or Novo's NovoSeven. Both drugs demonstrated an ability to stop bleeding episodes, with 93 per cent of incidents halted with three doses or less of either medicine.

The vatreptacog alfa findings contrast with previous research into NovoSeven, during which no anti-drug antibodies have previously been reported when used for haemophilia patients with inhibitors.

NovoSeven will soon lose patent protection and vatreptacog alfa had been touted as a replacement product for the company. However, the risks associated with development of anti-drug antibodies in patients taking vatreptacog alfa, including antibodies that also targeted NovoSeven, look to have ended Novo's hopes that the investigational drug would help cover the $1.43bn black hole in sales it faces from generic competition to NovoSeven.

Novo's financial results have already taken a hit from declining sales of NovoSeven, which fell six per cent during the first quarter of 2012.

The Danish pharma firm attributed this to "a low level of surgeries involving NovoSeven treatment, stricter budgetary controls in hospitals, a low level of acquired haemophilia cases and also an increase in inhibitor patients participating in clinical trials".

1st October 2012

From: Research

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Digitas Health

Digitas Health is the only digital-at-the-core brand agency designed to connect today's healthcare brands with today's healthcare consumers and professionals....

Latest intelligence

More of the same: The importance of strategic communications planning for biosimilar entry
GCI Health's Hannah Morris considers the importance of strategic communications planning for biosimilar entry, a market anticipated to deliver between €8-26bn in savings across the European Union by 2020....
Online Physician Communities
How can pharma realise the power of digital?
Firstly, by making it owned and driven by the most senior leadership team in the business...
Remapping the market: Does Pharma's global model need a shake up?
For patients, carers and professionals, wherever they are in the world, digital technology is inherent in their everyday lives. Digital is, so to speak, a global language. The success of...