Otezla FDA approval : US biotech company Celgene has bagged approval from the US Food and Drug Administration (FDA) for Otezla (apremilast) for the treatment of oral ulcers associated with Behcet’s Disease in adults.

The approved dosage of the oral, selective inhibitor of phosphodiesterase 4 (PDE4) is 30mg twice daily. According to Celgene, Otezla is the first and only approved treatment for oral ulcers associated with Behcet’s Disease. A rare, chronic, multisystem inflammatory disease, Behcet’s Disease or Behcet’s Syndrome is considered difficult to treat with oral ulcers being its most common manifestation. Occurring in over 98% of patients with Behcet’s Disease, the oral ulcers can be painful, disabling and negatively impact the quality of life.

Otezla FDA approval driven by Phase 3 Relief Clinical Trial

The Otezla FDA approval was driven by efficacy and safety data from the RELIEF study, a randomized, placebo-controlled, double-blind Phase 3 trial that assessed the PDE4 inhibitor in 207 adults with Behcet’s Disease with active oral ulcers who were treated previously with more than one nonbiologic medication and were also candidates for systemic therapy.

The RELIEF clinical trial demonstrated Otezla 30mg taken twice daily led to a 42.7 point reduction from baseline in the pain of oral ulcers as measured by the visual analog scale (VAS) at week no. 12. This was in comparison to an 18.7 point reduction with placebo.

Nearly 53% of patients treated with Otezla achieved an oral ulcer complete response (oral ulcer-free) at week no. 12, in comparison to 22.3% in the placebo arm.

Commenting on Otezla FDA approval, Yusuf Yazici – Clinical Associate Professor, Department of Medicine, New York University Langone Health, said: “Oral ulcers are a recurring and debilitating manifestation that affects nearly everyone living with Behçet’s Disease, and have an important negative impact on the quality of life for these patients.

“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.”

Apart from the latest Otezla FDA approval for oral ulcers associated with Behcet’s Disease, the PDE4 inhibitor is indicated in the US for moderate to severe plaque psoriasis, and for active psoriatic arthritis. Celgene claims that since the initial Otezla FDA approval in 2014, the PDE4 inhibitor has been prescribed to more than 250,000 patients in the US having moderate to severe plaque psoriasis or active psoriatic arthritis.

Terrie Curran – President of Celgene Inflammation & Immunology, commenting on the latest Otezla FDA approval, said: “We are excited to provide the first and only FDA-approved treatment for oral ulcers associated with Behçet’s Disease.

“This approval is a reflection of Celgene’s commitment to research in areas of high unmet need, including rare diseases such as Behçet’s Disease. We remain dedicated to further studying Otezla and its role in inflammatory conditions.”

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  apremilast, Behcet’s Disease, Behcet’s Syndrome, Celgene, Oral ulcers, Otezla, PDE4 inhibitor, Terrie Curran, US FDA, US Food and Drug Administration, USA, Yusuf Yazici