AbbVie Gets Closer to EU Approval of New Hepatitis C Drug

A committee for the European Medicines Agency has recommended approval for a hepatitis C drug combination, a key step to winning European marketing authorization for the drug maker AbbVie.

The recommendation for marketing authorization is for AbbVie’s investigational drug named Exviera (dasabuvir) and Viekirax (ombitasvir, paritaprevir and ritonavir) for the treatment of chronic hepatitis C virus (HCV) infection in combination with other medicine. The opinion adopted by the EMA’s Committee for Medicinal Products for Human Use (CHMP) at its November 2014 meeting is an intermediary step on Exviera and Viekirax’s path to patient access, according to an EMA statement.

The drug combination is being investigated for treatment of adults with chronic HCV infection genotypes 1 and 4 and includes patients with compensated cirrhosis.

The European Commission will review the opinionbefore handing down a final decision sometime in the first quarter of 2015, according to a statement issued by AbbVie. If approved the company would be allowed to market the drugs in all 28 European Union states and Iceland, Liechtenstein and Norway, the company said.

“The CHMP positive opinions mark an important milestone in our HCV development program and recognize the potential our treatment brings to people in Europe living with this chronic condition,” said Michael Severino, MD, AbbVie’s executive vice president of research and development said in the statement. “Our treatment has been developed with the goal of achieving high cure rates in a broad range of genotype 1 patients with low rates of discontinuation and relapse.”

Hepatitis C is a blood borne virus that if left unchecked can cause severe liver damage and liver cancer. The virus is considered a major public health challenge and affects up to 3.5% of the population in different European Union states, according to the EMA statement.

Both Exviera and Viekirax block proteins needed by the hepatitis C virus to replicate. Exviera is a nonnucleoside NS5B polymerase inhibitor (dasabuvir) and Viekirax is a fixed-dose combination ofan NS3/4 protease inhibitor (paritaprevir), an NS5A inhibitor (ombitasvir) and ritonavir, a potent cytochrome P450 3A4 inhibitor used as a pharmacokinetic enhancer.

The all oral drug treatmentbeing investigated does not require interferon injections, part of traditional HCV drug regimens known to cause severe side effects.If approved it would be added to a list of new HCV drug treatments that offer higher cure rates with less treatment time and fewer serious side effects.

To support the investigational drug application, AbbVie submitted clinical trial data from six pivotal Phase 3 studies that involved 2300 patients in more than 25 countries, according to the AbbVie statement. Other study data submitted included results from a Phase 2 study in patients without cirrhosis and preliminary findings from a study of patients with hepatitis C coinfected with HIV and another study involving transplant recipients new to HCV treatment.

AbbVie was granted accelerated assessment by the EMA when it submitted its drug application in May of this year. Such assessments are given to speed up patient access to new medicines when there is an unmet medical need, according to the EMA statement.