FDA Approves Pill for Psoriatic Arthritis
U.S health regulators have approved the sale of a new treatment for psoriatic arthritis through prescription. The drug, which comes in pill-form, will be the first treatment of its kind for the unusual type of arthritis, which is normally treated through scheduled injection.
The pill, sold under the brand name Otezla, is composed of the active ingredient apremilast, which works as an a powerful anti-inflammatory. Apremilast has proven in past clinical trials to effectively block the enzyme phosphodiesterase 4 (PDE4), which is associated with painful inflammation in soft tissue and joints.
Up until Otezla's approval, psoriatic arthritis was only treated with scheduled injections which were often a cocktail of non-steroidal anti-inflammatory drugs and disease modifying anti-rheumatic solutions, according to the American College of Rheumatology.
The disease itself, psoriatic arthritis, is a persistent ailment that affects approximately 15 percent of patients who have a skin rash condition called psoriasis. According to the American College of Rheumatology, the rash commonly leads to inflammation of the surface of the skin, can sometimes go deeper, inflaming the soft tissue between and around joints. Living long-term with untreated psoriatic arthritis has been known to result in joint damage and may warrant surgery.
Otezla, produced by Celgene Corp, was approved to join an already pre-existing list of effective psoriatic arthritis treatments under the condition that all pregnant women who use the drug are registered with the Food and Drug Administration (FDA) so that investigators can assess the risks of serious weight loss and other potential adverse effects.
The FDA is also recommending that patients subscribed the medication have their weight closely monitored by their doctors to ensure that no unexpected and severe weight loss occurs.
Otezla's approval was announced in a FDA release on March 21.
Mar 22, 2014 08:51 PM EDT