BMS files oral hep C treatment
pharmafile | November 5, 2013 | News story | Sales and Marketing | BMS, HCV, dvc, hep C
Bristol-Myers Squibb has filed its investigational hepatitis C treatment – the first oral regime without interferon or ribavirin – with authorities in Japan.
Japan’s Pharmaceutical and Medical Devices Agency will consider the combination of BMS’s NS5A replication complex inhibitor daclatasvir (DCV) and its NS3 protease inhibitor asunaprevir (ASV) as a treatment for chronic hepatitis C (HCV).
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.
The trial data – which includes a 5% rate of discontinuation due to adverse events – are to be presented today at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington.
“The all-oral regimen of DCV plus ASV in this study represents the potential for a significant advance in the treatment of HCV infection in Japan,” said Brian Daniels, BMS’s senior vice president, global development and medical affairs, R&D.
Circumventing the need for injectable interferon drugs, which can cause debilitating side effects, a new generation of oral HCV treatments is changing the market in this therapy area.
Gilead Science, widely seen as the leader in this race, saw its investigational treatment sofosbuvir last month came one step closer to approval in the US after an FDA advisory panel unanimously backed the drug ahead of a final decision in December.
It could be the first all-oral treatment for the genotype 2 and genotype 3 variants of the disease and analysts on average expect it to generate sales of $1.73 billion in 2014, according to Reuters data.
These new drugs – along with others such as Janssen’s pill simeprevir – could help boost the market for hepatitis C drugs to more than $100 billion over the next decade according to Bloomberg Industries.
Oral HCV regimens are expected to take significant market share from existing injectable interferon treatments, which include Roche’s Pegasys and Merck’s PegIntron.
Approximately 170 million people worldwide have HCV, a virus that infects the liver and can lead to cirrhosis and liver cancer.
BMS’s Phase II 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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