Health & Medicine
FDA Approves Celgene's 'Otezla' to Treat Psoriatic Arthritis
Benita Matilda
First Posted: Mar 24, 2014 07:28 AM EDT
The U.S. Food and Drugs Administration gave a green signal to Celgene's drug called Otezla to treat adults with active psoriatic arthritis (PsA).
Psoriatic arthritis (PsA) is a form of arthritis known to affect those with psoriasis - a disorder that causes joint pain, stiffness and swelling. Most adults are initially diagnosed with psoriasis and later with PsA. Tumor necrosis factor blockers (TNF), corticosteroids and interleukin-12/interleukin-23 inhibitor are treatments that are currently available for PsA.
"Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis," Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, said in a news statement. "Otezla provides a new treatment option for patients suffering from this disease."
The safety and effectiveness of the new medication "Otezla" was evaluated based on three different clinical trials that involved 1,493 patients with active PsA. Otezla is an inhibitor of phosphodieasterase-4 (PDE-4).
The researchers noticed that during clinical trials, patients who were treated with Otezla displayed an improvement in signs and symptoms of PsA. This included improvement in the swollen joints, tendons as well as improvement in the physical function compared to those taking placebos.
The federal agency cautions that patients who are treated with Otezla should monitor their weight regularly by a healthcare professional. If a clinically significant or unexplained weight loss occurs, the healthcare professional should immediately evaluate the cause of weight loss and most importantly, consider discontinuing the treatment.
Treatment with the new medication was linked to an increase in depression reports. The side effects seen during clinical trials include diarrhea, nausea and headache.
The federal agency also demanded a pregnancy exposure registry as a marketing requirement to evaluate the risk of the drug in pregnant women.
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First Posted: Mar 24, 2014 07:28 AM EDT
The U.S. Food and Drugs Administration gave a green signal to Celgene's drug called Otezla to treat adults with active psoriatic arthritis (PsA).
Psoriatic arthritis (PsA) is a form of arthritis known to affect those with psoriasis - a disorder that causes joint pain, stiffness and swelling. Most adults are initially diagnosed with psoriasis and later with PsA. Tumor necrosis factor blockers (TNF), corticosteroids and interleukin-12/interleukin-23 inhibitor are treatments that are currently available for PsA.
"Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis," Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, said in a news statement. "Otezla provides a new treatment option for patients suffering from this disease."
The safety and effectiveness of the new medication "Otezla" was evaluated based on three different clinical trials that involved 1,493 patients with active PsA. Otezla is an inhibitor of phosphodieasterase-4 (PDE-4).
The researchers noticed that during clinical trials, patients who were treated with Otezla displayed an improvement in signs and symptoms of PsA. This included improvement in the swollen joints, tendons as well as improvement in the physical function compared to those taking placebos.
The federal agency cautions that patients who are treated with Otezla should monitor their weight regularly by a healthcare professional. If a clinically significant or unexplained weight loss occurs, the healthcare professional should immediately evaluate the cause of weight loss and most importantly, consider discontinuing the treatment.
Treatment with the new medication was linked to an increase in depression reports. The side effects seen during clinical trials include diarrhea, nausea and headache.
The federal agency also demanded a pregnancy exposure registry as a marketing requirement to evaluate the risk of the drug in pregnant women.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone