EMA to review daclatasvir
pharmafile | January 9, 2014 | News story | Sales and Marketing | BMS, EMA, daclatasvir, hep C
European regulators are to conduct a speedy investigation into one of Bristol-Myers Squibb’s investigational drugs for chronic hepatitis C virus (HCV).
The marketing authorisation application for NS5A replication complex inhibitor daclatasvir is being given an accelerated regulatory review by the European Medicines Agency.
The submission includes the EU’s first all-oral and ribavirin-free investigational regimen – for use in treatment-naïve genotype 1, 2, 3 patients and protease inhibitor treatment failures.
With an eye to the chill financial wind which is blowing through pharma in Europe as governments seek to clamp down on their drugs bills, BMS says it will help ensure daclatasvir is reimbursed for HCV patients with high unmet needs – assuming it is shown the green light, of course.
Approximately 170 million people worldwide have HCV, a virus that infects the liver and can lead to cirrhosis and liver cancer, with nine million estimated to be living with the disease in the EU.
“Our extensive clinical trial programme has demonstrated that daclatasvir has potential use as a foundational agent for multiple HCV treatment regimens,” said Brian Daniels, BMS senior vice president, global development and medical affairs, R&D.
“If daclatasvir is approved, we would focus on helping to ensure its availability to patients with limited treatment options and would work with EU health authorities to ensure access is achieved as quickly as possible,” he added.
In November BMS filed the investigational treatment in Japan in combination with its own NS3 protease inhibitor asunaprevir (ASV) as a treatment for HCV – the first oral regime without interferon or ribavirin.
In a Phase III study, this regime achieved an 84.7% overall sustained virologic response (SVR) 24 weeks after the end of treatment in Japanese patients with chronic HCV genotype 1b, who were either not able to have interferon or who did not respond to interferon-based therapies.
This is the genotype that around 70% of the 1.2 million people living with HCV in Japan have, and it has one of the lowest response rates to current standard of care.
BMS wants daclatasvir approved for use in Europe in combination with other agents, including Gilead’s Sovaldi (sofosbuvir), which was approved by US regulators in December.
Sovaldi is the first in a new class of medications known as nucleotide analogue inhibitors, or ‘nukes’, designed to block a specific protein that the hepatitis C virus needs to copy itself: most patients will be treated with the $1,000-a-day drug for 12 weeks, resulting in a total list price of $84,000.
Analysts have forecast Sovaldi sales to reach an impressive $1.9 billion in 2014, and the drug has also been given a positive CHMP recommendation, which means it could be approved in Europe relatively soon.
Gilead’s pill is the first treatment that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for the use of the injectable interferon treatment.
Oral HCV regimens are expected to take significant market share from existing injectable interferon treatments, which include Roche’s Pegasys and Merck’s PegIntron, which can cause debilitating side effects.
Sovaldi is the second drug approved by the FDA recently to treat chronic HCV infection – in late November the US regulator also approved Janssen’s Olysio (simeprevir).
In 2011 the FDA approved two other pills for hepatitis C, both in the protease inhibitor class: Merck’s Victrelis (boceprevir) and Vertex Pharmaceuticals’ Incivek (telaprevir).
It is a potentially lucrative area for manufacturers: the market for hepatitis C drugs could rise to being worth more than $100 billion over the next decade, according to Bloomberg Industries.
Apart from ASV, BMS’s hepatitis C pipeline includes BMS-791325, a non-nucleoside inhibitor of the NS5B polymerase and it is also developing Lambda, an investigational type 3 interferon which may be an alternative to alfa-interferon in patients for whom an interferon-based regimen is sought.
Adam Hill
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