World Hepatitis Day – European Medicines Agency uses regulatory tools to facilitate patient access to innovative medicines

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25/07/2014

World Hepatitis Day – European Medicines Agency uses regulatory tools to facilitate patient access to innovative medicines

According to the World Health Organization (WHO), viral hepatitis kills 1.4 million people worldwide every year. That is as many as are killed by AIDS/HIV infections.

Viral hepatitis is caused by five different types of hepatitis viruses, hepatitis A, B, C, D and E, which can lead to the development of acute or chronic inflammation of the liver.

In Europe, hepatitis C virus (HCV) infection is a major public-health challenge. It occurs in between 0.4% and 3.5% of the population in different European Union (EU) Member States and is the most common reason for liver transplantation in the EU.

The treatment paradigm for chronic hepatitis C is currently shifting rapidly with the development of several new classes of direct-acting antivirals. These new medicines display high efficacy rates allowing patients with chronic HCV infection to be cured without the need for co-administration of interferon. Interferon-based therapies are associated with poor tolerability and potentially serious side effects, which can be difficult to manage and rule out a considerable proportion of HCV patients for therapy. In addition, not all patients respond to these treatments.

Over the past eight months, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing authorisation for three new medicines for the treatment of chronic HCV infection, two of which are the first representatives of new classes of direct-acting antivirals.

The EMA fosters innovation and is using all the regulatory tools available to facilitate early access for patients to a range of innovative therapeutic options. The CHMP’s positive opinion is the first step towards a new medicine becoming available to patients. Once a marketing authorisation has been granted by the European Commission, decisions about pricing and reimbursement are taken at the level of each Member State.

The CHMP assessed the benefits and risks of the first two candidates in this new wave of innovative medicines for chronic HCV infection through an accelerated assessment procedure. The EMA’s accelerated assessment mechanism aims to speed up the assessment of medicines that are expected to be of major public health interest, particularly from the point of view of therapeutic innovation.

The first medicine, Sovaldi (sofosbuvir), was authorised for marketing authorisation in January 2014 following a CHMP recommendation in November 2013, and the second medicine, Daklinza (daclatasvir), was recommended for marketing authorisation by the CHMP in June 2014.

The CHMP is also currently using this mechanism in the assessment of three new applications for innovative HCV infection medicines.

In addition, over the past eight months, the CHMP gave an opinion on the use of three medicines or combinations of medicines for the treatment of chronic HCV infection in compassionate use programmes. These programmes are intended to give patients with a life-threatening, long-lasting or seriously disabling disease access to treatments that are still under development.

The use of these tools ultimately contributes to a wider range of therapeutic options available to patients allowing the needs of more patients to be met.

The EMA supports World Hepatitis Day, which is taking place on Monday 28 July 2014.

World Hepatitis Day is held every year on 28 July to provide international focus for patient groups and people living with chronic hepatitis B and C. It aims to raise awareness and influence change in disease prevention and access to testing and treatment.

The World Hepatitis Alliance first launched World Hepatitis Day in 2008. The Alliance is a non-governmental organisation that represents hepatitis B and C patient groups from around the world. World Hepatitis Day is organised in partnership with the WHO.

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