Celgene Corporation announced on July 19 that the U.S. Food and Drug Administration (FDA) has approved Otezla® (apremilast) 30 mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behcet’s disease. Otezla, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the first and only approved treatment option for oral ulcers associated with Behcet’s disease, a rare, chronic, multisystem inflammatory disease that is difficult to treat.
“Oral ulcers are a recurring and debilitating manifestation that affects nearly everyone living with Behcet’s disease, and have an important negative impact on the quality of life for these patients,” said Yusuf Yazici, MD, clinical associate professor, Department of Medicine, New York University Langone Health. “In the clinical trial, Otezla demonstrated improvements in measures of oral ulcers at week 12. Otezla has the potential to be a needed treatment option for U.S. patients and their physicians, who previously had limited options available.”
Behcet’s disease, also known as Behcet’s syndrome, affects approximately 5 in 100,000 people in the U.S. Oral ulcers, the most common manifestation of Behcet’s Disease occurring in more than 98 percent of patients, can be painful, disabling and negatively affect quality of life.
“We are excited to provide the first and only FDA-approved treatment for oral ulcers associated with Behcet’s disease,” said Terrie Curran, president, Celgene Inflammation & Immunology. “This approval is a reflection of Celgene’s commitment to research in areas of high unmet need, including rare diseases such as Behcet’s disease. We remain dedicated to further studying Otezla and its role in inflammatory conditions.”
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