Tags: Gilead | hepatitis | Europe | drug

Gilead's Hepatitis C Combination Wins European Agency's Backing

Friday, 26 Sep 2014 08:48 AM

Gilead Sciences Inc. won the backing of the European Medicines Agency for a hepatitis C treatment that pairs its Sovaldi with another drug, ledipasvir, to deliver a one-two punch to the virus.

The combination, to be called Harvoni, was evaluated more quickly than usual because it addresses “a major European public-health challenge,” the London-based agency said today in a statement. The European Commission, the EU’s executive arm, usually follows the recommendations of the agency’s Committee for Medicinal Products for Human Use in deciding whether to approve treatments.

Sovaldi, whose pricing has drawn criticism from health-care purchasers around the world, blocks one type of protein the hepatitis C virus needs to reproduce itself, while ledipasvir blocks another type.

“These new regimens allow the cure of patients with chronic HCV infection without the need for treatments involving interferons, medicines which are associated with poor tolerability and potentially serious side effects,” the EMA said.

As many as 150 million people in the world live with chronic hepatitis C infection, according to the World Health Organization. The most common modes of infection from the blood- borne virus are unsafe injection practices, inadequate sterilization of medical equipment, and unscreened blood and blood products.

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Gilead Sciences Inc. won the backing of the European Medicines Agency for a hepatitis C treatment that pairs its Sovaldi with another drug, ledipasvir, to deliver a one-two punch to the virus.
Gilead, hepatitis, Europe, drug
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2014-48-26
Friday, 26 Sep 2014 08:48 AM
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