The Japanese Ministry of Health, Labor and Welfare has granted orphan status to Celgene’s Revlimid for two indications.

Japan granted orphan designation for Revlimid (lenalidomide) for the treatment of both anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q and in combination with dexamethasone for treatment-experienced multiple myeloma patients, Celgene said.

The product is approved for the anemia indication in the U.S. and Canada and in the EU, the U.S. and Switzerland for the multiple myeloma indication. It also is approved in Australia for patients with multiple myeloma whose disease has progressed after one therapy.