AbbVie’s new hepatitis C therapy accepted for Early Access to Medicines Scheme

AbbVie has announced that its new glecaprevir/pibrentasvir hepatitis C regimen has been accepted for inclusion in the UK's Early Access to Medicines Scheme (EAMS).

The investigational, pan-genotypic, ribavirin-free regimen has been granted a positive scientific opinion through the EAMS, meaning UK patients may now potentially gain access to the treatment while the relevant regulatory bodies continue to review the therapy.

The European Medicines Agency is still assessing this treatment as a cure for hepatitis C virus infection in patients across all genotypes. It now becomes the first hepatitis C treatment to be accepted for EAMS inclusion.

Dr Alice Butler, medical director at AbbVie UK, said: "AbbVie is proud to have entered into the voluntary EAMS and today's positive announcement marks another important step for patients with hepatitis C virus."

The EAMS provides access to promising medicines for UK patients prior to marketing authorisation when it has been deemed that a clear unmet clinical need exists.

Once it receives final approval, it will be reviewed by the National Institute of Health and Care Excellence (NICE) and, if found to be cost-effective, will be commissioned by NHS England within 30 days, rather than the standard three months.

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