Hep C treatment given Breakthrough Therapy status

Bristol-Myers Squibb’s late stage hepatitis C product has been designated a Breakthrough Therapy Designation by the FDA.

The company’s investigational DCV Dual Regimen (daclatasvir and asunaprevir) is a combination therapy for genotype 1b chronic hepatitis C infection (HCV). The special designation means that the FDA will work closely with the company to give the drug the best possible chance of being approved, and as quickly as possible.

Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. Only drugs which show early clinical evidence that the drug may substantially improve treatment compared to existing therapies can gain the status.

The drug combination was granted the special status based on data from ongoing Phase III trials of the all-oral combination regimen of DCV, an NS5A replication complex inhibitor, and ASV, an investigational NS3 protease inhibitor, without ribavirin.

The announcement marks the second time daclatasvir has been granted a Breakthrough Therapy Designation. BMS’s investigational all-oral 3DAA Regimen (daclatasvir/ asunaprevir/BMS-791325) was given the special status last year.

Daclatasvir is also being studied in combination with sofosbuvir high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients and patients infected with HCV genotype 3.

A highly competitive market

BMS has a number of other HCV compounds in the pipeline, which will help make it one of the dominant players in the field over the next decade.

But BMS’s portfolio of HCV treatments will face some very strong competition. The FDA has also given Breakthrough Status to AbbVie’s triple drug regimen, which the firm is set to submit to regulators in the second quarter of 2014.

AbbVie has a new three-pronged drug hepatitis C regimen which analysts say could transform treatment of the disease.

Another strong contender is Gilead’s Sovaldi (sofosbuvir), which was launched in the US in December.

AbbVie’s ace card is that its regimen eliminates the need for interferon in genotype 1 patients. This outdoes Gilead’s Sovaldi, which currently can only be used without interferon in those patients who could not tolerate or take interferon, or who were awaiting a liver transplant.

Both drug regimens have delivered impressive results in cutting treatment time, raising ‘cure’ rates (measured by ‘sustained viral response’) and simplifying treatment for patients.

AbbVie’s three-pronged hepatitis C regimen can be used with or without ribavirin for genotype 1 sufferers, the most common variant of the disease.

Both AbbVie’s regimen and Sovaldi have achieved SVR rates above 90% making them significantly more effective than existing treatments in virtually eliminating the virus from patients.

Blockbusters sales are expected for all three drugs, and analysts predict Gilead’s drug will reach $5 billion sales by 2015, with AbbVie and BMS not far behind.

Links

FDA’s 37 breakthrough designations in 2013 ‘were little help’ to small biotechs

Janssen’s leukaemia drug receives third FDA breakthrough therapy designation

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