AbbVie Gets Breakthrough Therapy Designation to Test Pan-genotypic Hepatitis C Drug

The investigational drug that AbbVie is testing in clinical trials is a pan-genotypic regimen of glecaprevir and pibrentasvir, a co-formulation dosed once a day, according to the release.

The US Food and Drug Administration (FDA) has given AbbVie a breakthrough therapy designation for an investigational pan-genotypic drug regimen that the drugmaker is currently developing to treat hepatitis C, the company announced.

Breakthrough therapy designation by the FDA serves to accelerate the review process. It is granted to investigational drugs that treat serious or life-threatening conditions with preliminary clinical evidence that demonstrate substantial improvement over existing therapies, stated an AbbVie release.

The company said it was given the FDA designation based on results from its phase 2 clinical trial for patients with genotype 1 hepatitis C virus whose previous therapy attempts with direct-acting antiviral drugs were unsuccessful.

"AbbVie is committed to advancing HCV care and addressing areas of continued unmet need for people living with chronic HCV," Michael Severino, MD., AbbVie’s executive vice president of research and development and chief scientific officer, said in the release. "The FDA's Breakthrough Therapy Designation is an important step in our effort to bring our pan-genotypic regimen to market, which we are also investigating as an eight-week path to virologic cure for the majority of patients."

The liver-damaging hepatitis C virus has a high degree of genetic diversity. While the most common of the six strains is genotype 1, there are five other strains and drug makers have been working on developing one drug that can treat all strains of the virus.

Earlier, this year Gilead Sciences, which makes the blockbuster hepatitis C drug Sovaldi, received approval for its drug Epclusa, the first pan-genotypic drug approved to treat the virus. Epclusa is a once-daily single tablet that combines the drugs Sovaldi and velpatasvir for a typical 12-week dosing regimen.

The investigational drug that AbbVie is testing in clinical trials is a pan-genotypic regimen of glecaprevir and pibrentasvir, a co-formulation dosed once a day, according to the release. Glecaprevir is a NS3/4A protease inhibitor being developed in collaboration with Enanta Pharmaceuticals and pibrentasvir is a NS5A inhibitor, according to a release issued by Enanta.

AbbVie company executives plan to present new data from a Phase 3 study aimed at evaluating the safety and efficacy of the investigational regimen of glecaprevir and pibrentasvir across all six major HCV genotypes at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), in Boston next month, a company spokesperson said.

In the past few years, the FDA has approved several direct-acting antiviral drugs to treat hepatitis C. Developed by a handful of drug companies including AbbVie, the new regimens have higher success rates and work faster with fewer side effects than previous traditional treatments with interferon.

Earlier this year, AbbVie received FDA approval for VeiKira XR, once daily, extended-release tablets to treat chronic hepatitis C virus. The regimen combines the drugs ombitasvir, paritaprevir and dasabuvir along with ritonavir tablets.

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