AstraZeneca's tremelimumab granted orphan designation by FDA

16 April 2015

Anglo-Swedish drug major AstraZeneca (LSE: AZN) has been granted orphan drug designation by the US Food and Drug Administration for tremelimumab in the treatment of malignant mesothelioma.

The drug is designed to stimulate the immune system and enable it to destroy cancer cells through the binding to the protein CTLA-4, expressed on the surface of activated T-lymphocytes. Tremelimumab is being investigated as a monotherapy for patients with mesothelioma.

Robert Iannone, head of immuno-oncology, global medicines development at AstraZeneca, said: “Our aim is to rapidly advance the development of tremelimumab as a potential new treatment option for these patients.” AstraZeneca plans to file for US approval in the first half of next year.

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