The Ministry of Food and Drug Safety on Monday approved the local sales of Otezla (ingredient: apremilast), a new oral treatment for psoriasis developed by U.S. biotech firm Celgene. Psoriasis is a long-lasting autoimmune disease characterized by patches of abnormal skin.
The government’s approval recognizes that Oztela can work on adult patients with psoriatic arthritis who either failed to be cured by existing disease-modifying anti-rheumatic drugs (DMARDs) or do not have drug tolerance against DMARDs. It also treats adult patients with moderate to severe plaque psoriasis who receive phototherapy and systemic treatment.
Unlike biological products such as Stelara (ingredient: ustekinumab) and Cosentyx (ingredient: secukinumab) which are interleukin inhibitors, Otezla inhibits an enzyme called phosphodiesterase 4 (PDE4) to regulate inflammation in patients with psoriatic arthritis.
PDE4 is presumed to involve in inflammation inside the inflammatory cells. Experts have not confirmed the exact mechanism of Otezla yet. However, they assume that the drug indirectly reduces overly sensitive inflammatory cells by blocking PDE4’s activation.
Otezla received the U.S. FDA approval in 2014 as a treatment for psoriatic arthritis and psoriasis. In 2015, it also won the sales approval in Europe.
Psoriasis develops among 1 percent of the world’s population. In Korea, its incidence rate is 0.5-1 percent.
Oztela’s most common side effects include diarrhea, nausea, and headache occur in the first week after the start of the treatment. The side effects reportedly decrease with time. Some cases of weight losses were also reported. The elderly and people who take anti-hypertensive drugs should take extra caution in the use of Oztela.
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