EU OKs Otezla, Celgene's first-in-class pill for patients with psoriasis, psoriatic arthritis
Celgene's new immune disorder drug, Otezla, has been approved in Europe for treating both psoriasis and a related type of arthritis, the company said Friday.
Otezla, known chemically as apremilast, is the first new pill approved for psoriasis patients in 20 years and for patients with psoriatic arthritis in the last 15 years, according to Celgene Corp.
The medicine is the first in a new class of treatments and works by blocking an enzyme called PDE4, or phosphodiesterase 4, and that is believed to affect substances involved in inflammation. It was approved by the European Commission for patients with moderate or severe psoriasis, or acute psoriatic arthritis, in whom other treatments either didn't work or aren't appropriate.
The two conditions are chronic inflammatory disorders involving the immune system. Psoriasis causes unsightly, raised reddish and silvery white scales on the skin, from small patches to all over the body. Psoriatic arthritis causes pain, stiffness and swelling in joints and limits physical function.
The drug was approved in the U.S. last March. The company said it brought significant improvement after 16 weeks of treatment. Side effects among patients receiving it in clinical studies include diarrhea, nausea, headaches and upper respiratory infections and, in about 1 percent of them, depression. It is not to be taken by women who may become pregnant.
Celgene is based in Summit, New Jersey.