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24 Dec 2016

Celgene’s Otezla (Apremilast) receives Japanese regulatory approval

Brand Name: Otezla
Molecule: Apremilast
Developed By: Celgene Corporation

Apremilast (brand name Otezla) is a medication for the treatment of certain types of psoriasis and psoriatic arthritis.

US approval

Apremilast was approved by the United States Food and Drug Administration in 2014 for treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis.

Japan

Now Otezla has been granted full marketing authorization by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the treatment of adult patients with plaque psoriasis with an inadequate response to topical therapies, as well as adult patients with psoriatic arthritis.

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Basis of Approval 

The approval was based on efficacy and safety results from an international phase 2b study (PSOR-005), international phase 3 studies, ESTEEM-1 and 2, and a Japanese phase 2b study (PSOR-011) conducted in adult patients with moderate to severe plaque psoriasis, and international phase 3 studies, PALACE-1,2 and 3, conducted in adult patients with psoriatic arthritis.

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