EMA Starts Accelerated Review of G/P Regimen, Possible Treatment Option for Severe CKD

EMA Starts Accelerated Review of G/P Regimen, Possible Treatment Option for Severe CKD

The European Medicines Agency (EMA) has begun an accelerated review of AbbVie’s marketing authorization application for a glecaprevir/pibrentasvir (G/P) regimen to treat major Hepatitis C virus (HCV) genotypes, and as a potential alternative treatment option for patients with specific challenges, including those with severe chronic kidney disease (CKD).

An accelerated review is given to medicines of major public health interest, and is intended to possibly bring them to market more quickly. If approved, the regimen could be available to patients in the second half of this year.

Glecaprevir and pibrentasvir are inhibitors of Hepatitis C virus proteins important for viral replication. G/P combines these two antiviral agents in a fixed-dose combination — glecaprevir (300 mg) and pibrentasvir (120 mg) — to be taken once daily as three oral tablets for eight weeks.

Glecaprevir is Enanta Pharmaceuticals’ second viral protease inhibitor developed together with AbbVie. Pibrentasvir is an NS5A inhibitor. According to a press release, the marketing application 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 G/P regimen is designed to provide a shorter, once-daily treatment option — and possible cure — for patients with any HCV genotype (1-6) without cirrhosis, who are also new to treatment with direct-acting antivirals. It is also being evaluated in patients with chronic kidney disease, including those on dialysis, and in HCV patients not cured by previous treatments with direct-acting antivirals.

AbbVie submitted a New Drug Application submission for G/P to the U.S. Food and Drug Administration (FDA), requesting its approval as treatment of chronic HCV infection (genotypes 1-6) in December.

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