About the API
Apremilast, which belongs to a class of anti-inflammatory agents that are non-steroidal in nature, modulates a wide range of inflammatory mediators involved in psoriasis and psoriatic arthritis. It presents a novel approach that does not target a single mediator, but rather focuses on restoring a balance of pro-inflammatory and anti-inflammatory signals. Apremilast is indicated for the treatment of adult patients with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. It is administered orally.
Apremilast was approved by the FDA in March 2014 under the brand name Otezla for treatment of adults with active psoriatic arthritis. It was the first oral agent approved for the treatment of psoriatic arthritis. In September 2014, the FDA approved Otezla for the treatment of moderate to severe plaque psoriasis. The manufacturing process consists of three main steps: i) blending and lubrication ii) compression iii) coating.