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EMA Proposes Updating Hepatitis B Guide To Support Drugs Aiming For ‘Functional Cure’

 
• By Vibha Sharma

Since the European Medicines Agency adopted its hepatitis B guideline in 2006, the treatment goal of ‘functional cure’ has evolved and changed the development landscape of agents intended for the treatment of chronic infection.

Human hand hold care liver health therapy, Liver cancer, cancer, donation liver, disease, donation, Hepatitis, cirrhosis, Hepatitis B virus, HBV, Vaccine, insurance, hospital.World hepatitis day
Nearly 300 million people globally are living with chronic hepatitis B • Source: Shutterstock

The European Medicines Agency is inviting stakeholder feedback on plans to update its hepatitis B medicines guideline to clarify the requirements for new products that aim to achieve a “functional cure,” have novel mechanisms of action and/or are intended for finite (time-limited) or combination treatment approaches.

The EMA’s proposal is outlined in a draft concept paper in which the agency explains that its current guideline on the clinical evaluation of medicines for hepatitis B, in...

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