Regulatory Focus™ > News Articles > UK Patients to Get Early Access to AbbVie's HCV Combo

UK Patients to Get Early Access to AbbVie's HCV Combo

Posted 10 May 2017 | By Michael Mezher 

UK Patients to Get Early Access to AbbVie's HCV Combo

Patients in the UK will get early access to AbbVie's experimental pan-genotypic hepatitis C (HCV) drug combination, the Medicines and Healthcare products Regulatory Agency (MHRA) announced Wednesday.

The combination, known as glecaprevir/pibrentasvir, is currently undergoing an expedited review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for its potential to treat patients across all six major genotypes of HCV, with or without cirrhosis, in as little as eight weeks.

However, the investigational drug will be made available to UK patients with certain hard to treat or advanced forms of the disease before it is approved under the country's early access to medicines scheme (EAMS).

MHRA first announced the EAMS program in March 2014 as a means of speeding access to potentially lifesaving medicines to treat medical conditions with high unmet need.

The announcement marks the first time a treatment for HCV has been accepted to the program, which has primarily focused on accelerating access to unapproved cancer drugs. Aside from glecaprevir/pibrantasvir, only two other non-cancer treatments have been accepted to the program: Sanofi's Dupixent (dupilumab) to treat severe atopic dermatitis and Novartis' Entresto (sacubitril/valsartan) to treat heart failure.

MHRA says it based its decision to accept glecaprevir/pibrentasvir to the EAMS program on the results of three Phase II studies M15-410 (Parts 1 and 2), M15-462 and M14-868 (Part 3). According to the agency, more than 90% of patients in each of the three subsets showed no sign of the disease 12 weeks after completing the treatment.



© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.