21. December 2011 15:14
The Marketing Authorisation Application for Gilead Sciences Quad single-tablet regimen for the treatment of HIV-1 has been validated by the EMA.
The application is supported by results from two Phase III studies which demonstrated the tablet’s safety and efficacy data and by clinical data for the individual components of the Quad and Chemistry, Manufacturing and Controls (CMC) information.
Norbert Bischofberger, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences, says Gilead is working with the regulator “to bring this new single-tablet regimen to physicians and patients as quickly as possible”.
The regimen contains elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate and was submitted to the EMA in November 2011. The submission to the FDA was made in October 2011.
Gilead’s first single-table regimen, Atripla, was approved in the EU in 2007. Its second single-tablet regimen, Eviplera – which combines its Truvada and Tibotec Pharmaceutical’s rilpivirine – was approved in the EU in November 2011.
“Based on the safety and efficacy data from the Phase 3 pivotal studies, we believe the Quad single-tablet regimen has the potential to be a convenient treatment option for patients new to HIV therapy,” said Norbert Bischofberger.
5. December 2011 12:13
Bristol-Myers Squibb has entered into a clinical collaboration with Janssen’s Tibotec Pharmaceuticals for the treatment of chronic hepatitis C virus (HCV).
The two will evaluate the utility of BMS’ daclatasvir (BMS-790 052) and Tibotec’s TMC435 in a series of trials.
Brian Daniels, Senior Vice President, Development, BMS, says the agreement is “a continuation of our leadership in forging partnerships to advance combination antiviral therapy”.
As part of the clinical trials, the companies will evaluate sustained viral response at 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens. These are: a once-daily treatment regimen of daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin; a once-daily treatment regimen of daclatasvir and TMC435 with ribavirin and a once-daily treatment regimen of daclatasvir and TMC435 alone.
Daclatasvir was discovered by BMS through a genomics approach and is the first NS5A replication complex inhibitor to be investigated in clinical trials. It is currently in Phase III development.
“Bristol-Myers Squibb is dedicated to developing innovative treatment options for patients with serious diseases like HCV,” said Brian Daniels. “We are pleased to work with Tibotec to advance the scientific understanding for the potential for an all-oral regimen of direct acting antivirals, which would be an important advancement for patients with HCV.”
The studies are planned to commence in the first half of 2012.