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Apremilast (brand name Otezla, by Celgene) is a drug for the treatment of certain types of psoriasis and psoriatic arthritis. It may also be useful for other immune system related inflammatory diseases.
We expect to file a Biologic License Application (BLA) shortly thereafter. We expect to file a Biologic License Application (BLA) shortly thereafter. The role of the BRMAC is to make recommendations, which are not binding, to the FDA on the clinical sections of Biologic License Applications (BLAs).