FDA Approves New Drug for Psoriatic Arthritis
In a statement released on March 21, 2014, the U.S Food and Drug Administration announced that the FDA approved a new drug to treat adults with active psoriatic arthritis (PsA). The new drug is “Otezla”, and Bill Berkot, in “Update 2- U.S. FDA Approves Drug for Psoriatic Arthritis,” explains that it is an effective version of the drug Celgene, repurposed to treat PsA symptoms that includes joint pain, stiffness and swelling.
Otezla, which works by blocking enzymes associated with inflammation, is presented as an alternative to currently approved treatments for PsA, including corticosteroids and tumor necrosis factor (TNF) blockers. Though TNF blockers are highly effective, they have more potentially serious side effects than Otezla. Patients may show more compliance towards Otezla as it comes in pill form; current leading treatments are injected drugs.
Researchers performed clinical trials on 1,493 patients with active PsA to determine the safety and effectiveness of Otezla, with treatment goals such as relief of pain and inflammation and improving physical function. In the three clinical trials, patients treated with Otezla showed improvement in signs and symptoms of PsA, including tender and swollen joints and physical function, compared to placebo.
Researchers noted that the most common side effects observed in patients were diarrhea, nausea, and headache. However, the drug can cause significant weight loss, depression, and potential pregnancy complications. The FDA notes that healthcare professionals should regularly monitor the weight of patients treated with Otezla, and should reevaluate the treatment if the patient experiences unexplained, significant weight loss. Furthermore, The FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure.
Berkot anticipates orders for the drug to begin this month, and the FDA is expected to make a decision by September 2014 on the safety and effectiveness of Otezla for plaque psoriasis.
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