Polaris Group receives orphan drug designation for ADI-PEG 20 from the FDA
Privately-held Polaris Group has received orphan drug designation for ADI-PEG 20 (pegylated arginine deiminase) from the US Food and Drug Administration.
The designation has been granted for the treatment of malignant pleural mesothelioma in the USA and the European Union, following a successful randomized Phase II trial in argininosuccinate synthetase-deficient MPM patients with ADI-PEG 20 as monotherapy.
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