AbbVie’s marketing authorization application (MAA) for its investigational drug glecaprevir/pibrentasvir (G/P), developed as a treatment for chronic hepatitis C virus (HCV) genotypes 1 to 6, has been validated by the European Medicines Agency (EMA) and is now under accelerated assessment.
If approved, G/P could provide a shorter eight-week, once-daily treatment option for most HCV patients without cirrhosis, and could become available in Europe in the second half of 2017.
G/P was also developed as an alternative treatment option for patients with compensated cirrhosis, a liver disease where patients experience few to no symptoms, and for patients with specific treatment challenges, including severe chronic kidney disease and patients not cured with other direct-acting antiviral treatments.
Glecaprevir and pibrentasvir are inhibitors of HCV proteins important for viral replication. G/P combines these two distinct antiviral agents as a fixed-dose combination — glecaprevir (300 mg) and pibrentasvir (120 mg), taken once daily as three oral tablets.
Glecaprevir is Enanta Pharmaceuticals‘ second viral protease inhibitor developed together with AbbVie.
According to an Enanta press release, the MAA for G/P is supported by data from eight studies in the drug’s clinical development program, which evaluated over 2,300 patients in 27 countries.
The drug was tested in patients with different HCV genotypes, patients without cirrhosis and with compensated cirrhosis, patients new to and experienced in treatment, and patients with specific treatment challenges.
The EMA will now review the G/P regimen under accelerated assessment – the designation for new medicines of major public health interest and therapeutic innovation. Validation of the MAA confirms the completion of the submission and starts the review process.
In December 2016, AbbVie announced it had submitted a New Drug application (NDA) for G/P to the U.S. Food and Drug Administration (FDA) for the treatment of chronic HCV infection in genotypes 1 to 6.
The company also reported it remained on track to submit an NDA for the G/P regimen as an HCV treatment in Japan in early 2017. As previously reported, the G/P investigational drug therapy harnessed the infection in all patients who completed a Japanese study, part of a Phase 3 open-label clinical trial (NCT02707952; CERTAIN-1).