Please login to the form below

Not currently logged in
Email:
Password:

Shire’s bleeding disorder drug approved in Europe

Veyvondi for patients with rare disease von Willebrand disease

Shire

The European Commission (EC) has given the green light to Shire’s haemostatic disorder treatment Veyvondi, which is now set to prevent surgical bleeding in adults with von Willebrand disease (VWD).

Administered as an injection, the drug is now the first and only recombinant von Willbrand Factor (rVWF) treatment approved in the EU that specifically treats the primary deficiency of VWF, one of several types of proteins in the blood that are needed to facilitate proper blood clotting.

Patients with VWD usually are deficient in this protein, and affected individuals have symptoms including nosebleeds, bleeding from the gums and easy bruising. Bleeding from the stomach and intestines can occur but it is less common.

Importantly, Veyvondi allows the body to not only restore adequate VWF levels but maintain them also.

Andreas Busch

Andreas Busch, head of research and development and chief scientific officer, Shire, said: “The approval in Europe for VEYVONDI marks a key milestone in our efforts to tackle unmet medical needs for those living with von Willebrand disease.”

VWD is the most common inherited bleeding disorder, affecting up to 1% of the global population and 100,000 people in the EU.

Busch added: “We are excited to take the next steps in ensuring that Veyvondi is widely available across Europe to address the individual needs of those affected by the condition and in need of factor replacement."

The European Regulator’s decision was based out data from three clinical trials assessing tolerability, pharmacokinetics, safety and efficacy of the drug.

The drug has been approved in the US for more than two years under the brand name Vonvendi, indicated for use in adults diagnosed with VWD for on-demand treatment and control of bleeding episodes or perioperative management of bleeding.

Article by
Gemma Jones

13th September 2018

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Apex.co.uk Conferences, Events and Exhibition Stands

Apex.co.uk is one of the UK’s leading event and exhibition agencies, specialising in healthcare. We understand your communication goals, whether...

Latest intelligence

World Diabetes Day: Interaction and impact of diabetes on mental health
For World Diabetes Day on the 14th November 2018, Nisha Shahrukh - Medical Writer at Mednet Group has written an article depicting the impact diabetes has on mental health. Including...
EU
Innovation in merger control and the impact on the pharmaceutical sector
Is focusing on pipeline products enough to assess regulatory risks?...
Nudge-nudge, think-think
Chris Ross examines the personal complexities of human behaviour – and explains why fun, emotion and peer endorsement could be key to designing effective behavioural change programmes...

Infographics