March 21 U.S. health regulators on Friday
approved a Celgene Corp drug to treat psoriatic
arthritis, a type of arthritis associated with the skin disease
psoriasis that causes joint pain, stiffness and swelling.
The drug, known chemically a apremilast, will be sold under
the brand name Otezla. It is also being studied by the U.S.
biotechnology company as a treatment for psoriasis and
"Relief of pain and inflammation and improving physical
function are important treatment goals for patients with active
psoriatic arthritis," Curtis Rosebraugh, director of the Food
and Drug Administration Office of Drug Evaluation II, said in a
"Otezla provides a new treatment option for patients
suffering from this disease," he added.
As a condition of approval, the FDA is requiring a registry
of pregnant women who use the drug to assess the risks to
pregnant women related to Otezla exposure, the agency said.
It also said Otezla patients should be monitored for
potentially significant weight loss. If unexplained or
clinically significant weight loss occurs, the weight loss
should be evaluated and discontinuation of treatment should be
considered, the FDA said.
(Reporting by Bill Berkrot; Editing by Tom Brown)