In Japan, Celgene's Revlimid gets approval; Astellas to file degarelix and inks vaccine deal with UMN
US drugmaker Celgene (Nasdaq: CELG) has been granted full marketing authorization by Japan's Ministry of Health, Labor and Welfare (MHLW) for its drug Revlimid (lenalidomide) in the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. The drug was also approved in June in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.
The approval of Revlimid was based upon the safety and efficacy results of several international trials in patients with deletion 5q MDS, which have supported regulatory approval in 19 countries worldwide.
As a result of the approval, Revlimid will be available through RevMate, the company's proprietary distribution program. Celgene is now registering physicians and medical centers throughout the country into RevMate as part of its strategic launch.
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