FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EU’s Supreme Court Sides With Italian Authorities on Off-Label Uses

Dec. 4, 2018
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The EU’s supreme court has ruled that EU member state health systems can cover the cost of off-label drug uses in certain cases.

The decision by the European Court of Justice settles a case from Italian authorities who sought approval to reimburse for the cost of cancer drug Avastin (bevacizumab) for treatment of age-related macular degeneration.

Avastin is not approved for this use but is considerably cheaper than Lucentis (ranibizumab), which is indicated specifically for the vision problem. Both drugs are manufactured by Roche, but Lucentis is marketed by Novartis outside of the United States.

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