AbbVie's Glacaprevir/Pibrentasvir Recommended for EMA Approval

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Medicines Agency (EMA) grant market authorization to Abbvie’s glacaprevir/pibrentasvir (MAVIRET) — an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus (HCV) infection.

If approved, glacaprevir/pibrentasvir will provide a shorter, 8-week, pan-genotypic (GT1-6), once-daily option for the majority of people living with HCV — specifically, those without cirrhosis and who are new to treatment across all genotypes, according to an AbbVie statement.

The drug may also work as an additional option for patients who are facing challenges in treatment, like chronic HCV patients with compensated cirrhosis (Child-Pugh A), and those who currently have limited treatment options, like patients with severe chronic kidney disease, including those on dialysis, and patients infected with genotype 3. However, glacaprevir/pibrentasvir’s safety and efficacy have not been established.

“MAVIRET represents a new generation of HCV therapy and has the potential to be a shorter, 8-week option for patients living with this serious, chronic illness,” said Michael Severino, MD, executive vice president of research and development, and chief scientific officer at Abbvie.

According to a company statement, the EMA has granted accelerated assessment to AbbVie’s marketing authorization application for glacaprevir/pibrentasvir because it is a new medicine of major public health interest, the statement said. If approved, the drug will receive marketing authorization valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

CHMP’s positive opinion on glacaprevir/pibrentasvir is supported by 97.5% SVR₁₂ rates with 8 weeks of the drug across GT1-6 chronic HCV infected patients without cirrhosis and who are new to treatment, with varied patient and viral characteristics. Less than 0.4% of patients discontinued treatment.

Adverse reactions included headache and fatigue. The type and severity of adverse reactions in patients with cirrhosis were overall comparable to those seen in patients without cirrhosis, according to an Abbvie statement.

“In clinical studies, MAVIRET demonstrated high SVR rates across all genotypes of HCV patients (GT1-6). If approved, MAVIRET would remove many of the complexities of pre-treatment patient evaluation and has the potential to help facilitate the care and management of HCV,” said Stefan Zeuzem, MD, chief of the department of medicine at the JW Goethe University Hospital in Frankfurt, Germany.

Glacaprevir/pibrentasvir is a fixed-dose combination of two distinct antiviral agents. Glecaprevir (100mg) is an NS3/4A protease inhibitor that was discovered during a collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors. Pibrentasvir (40mg) is an NSSA inhibitor. The regimen is dosed once-daily as three oral tablets.