Please login to the form below

Not currently logged in
Email:
Password:

BMS drops US application for 'breakthrough' hep C combination

Blames the 'rapidly evolving' market for asunaprevir withdrawal

Bristol Myers Squibb logo Bristol-Myers Squibb has withdrawn its US application for asunaprevir and daclatasvir, eight months after the combination hepatitis C treatment was received 'breakthrough' status from the FDA.

The move will not stop it pursuing US approval of daclatasvir, or affect its plans for the combination in certain other markets, but it does spell the end of asunaprevir's chances in the US.

BMS said its decision was prompted by the “rapidly evolving” hepatitis C treatment landscape in the US.

The combination of NS5A replication complex inhibitor daclatasvir and asunaprevir, a NS3/4A protease inhibitor, was originally developed to meet the need of the Japanese patient population.

It was approved by Japanese regulators in July and BMS said the dual regimen still has a key role in curing patients in that country “as well as in other markets where the HCV patient population is similar to Japan”.

BMS plan to submit additional data from daclatasvir to the FDA from an ongoing trial programme in difficult-to-treat patients, including patients with HCV genotype 3, patients who are pre- and post-liver transplant and patients co-infected with HIV.

In the EU, daclatasvir - marketed as Daklinza - was recently approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 of HCV. The drug has a European licence for use in combination with Gilead's Sovaldi (sofosbuvir).

Article by
Kirstie Pickering

8th October 2014

From: Research, Sales

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Anthill Agency

Digital communications agency empowering clients through their digital transformation journey. Whether through training, delivering solutions or devising digital strategies, we...

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