- Category: Latest Updates
- Published on Tuesday, 31 July 2012 16:43
Will enable to save precious time off their predicted timeline for a new drug application
Idenix Pharmaceuticals, the Cambridge-based biotechnology company, announced that its drug, IDX719, was granted a Fast Track designation by the FDA. IDX719, an NS5A inhibitor, is designed to treat chronic hepatitis C virus (HCV) infection in patients. The Fast Track designation will enable Idenix Pharmaceuticals to save precious time off their predicted timeline for a new drug application (NDA), and even increase interaction with the FDA to guarantee a quicker review and a shorter time to market.
HCV is a causative agent of chronic liver infections, which often leads to serious problems such as liver cirrhosis, liver failure or cancer. HCV infection is currently considered a worldwide problem with high incidence of infection attributed to improper injection practices and unsafe blood transfusions in low and high-income countries, alike. Estimates from the World Health Organization (WHO) indicate that the current disease burden is a staggering three per cent of the world’s population. HCV causes an asymptomatic infection in most individuals, but almost 25 per cent of infected persons eventually begin to display symptoms. Data also indicates that approximately 60-80 per cent of symptomatic patients may develop a chronic infection resulting in chronic liver disease.
Currently, there exists no complete cure or prophylactic treatment for HCV infection. The global disease burden of HCV and the large unmet need for an effective HCV vaccine are the strongest drivers within this market today. Idenix’s IDX719, has a wide ranging in vitro activity profile across various HCV genotypes. Phase I trials indicate that the drug can be used against the most prevalent genotypes of HCV, 1, 2 and 3, which will increase the likely prescribed indication and use of IDX719 across the different HCV subtypes.
Idenix’s HCV pipeline is robust and promising. The company’s lead drug candidate, IDX184, is presently undergoing phase IIb trials. IDX184, a nucleotide inhibitor, is designed to target the liver through a once-a-day orally administered pill, which will provide the patient and healthcare professionals with access to an easy dosing regimen and a convenient administration route.
While it is currently unclear if Idenix will choose to cultivate its commercial and manufacturing base or out-license this drug, the move to Fast Track designation may also be seen as a reinforcement of the potential impact that these drugs may have on the HCV market. This virtually untapped blockbuster market is likely to change the face of Idenix, giving it the flexibility to diversify its portfolio beyond HCV and HIV.
The development of an antiviral in the HCV market is bound to provide relief to millions of infected individuals; however, most believe that the true silver bullet is an effective HCV vaccine. Until then, however, it is likely that we will see the antiviral market diversify, grow and even mature in the future. Idenix proposes that the HCV treatment paradigm favours the use of a combinatorial approach, where a cocktail of antiviral drugs will increase potency of the immune response and inhibit replication. For this reason, Idenix recognises that it will require the contributions of other companies, such as Abbott, Bristol-Myers Squib and Gilead to collectively decrease infection prevalence.
EP News Bureau