Celgene has secured approval from the US Food and Drug Administration (FDA) for its Otezla (apremilast) 30mg twice daily (BID) to treat adult patients with oral ulcers associated with Behçet’s Disease.
Otezla (apremilast) 30mg is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), particularly for cyclic adenosine monophosphate (cAMP).
It is claimed to be the first and only approved treatment option for oral ulcers associated with Behçet’s Disease, which is a rare, chronic and multisystem inflammatory disease.
The latest approval was based on efficacy and safety data from the randomised, placebo-controlled and double-blind phase 3 Relief study assessing Otezla in 207 adult patients with Behçet’s Disease with active oral ulcers who were previously treated with at least one nonbiologic medication and were candidates for systemic therapy.
According to the company, the results demonstrated that Otezla 30mg BID resulted in a 42.7 point reduction from baseline in the pain of oral ulcers as measured by the visual analog scale (VAS) at week 12 compared against 18.7 point reduction with placebo.
Earlier, Otezla was approved in the use to treat patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, as well as adult patients with active psoriatic arthritis.
The company is expecting a regulatory decision for Otezla in oral ulcers associated with Behçet’s Disease from the Pharmaceuticals and Medical Devices Agency in Japan in the second half of this year.
Earlier this year, Celgene also submitted a Type II Variation to the marketing authorisation of Otezla for approval in the European Union.
Relief study is a phase 3 randomised, placebo-controlled and double-blind study assessing Otezla 30mg BID in 207 adult patients with Behçet’s Disease with active oral ulcers who were previously treated with at least one nonbiologic medication and were candidates for systemic therapy. The company has conducted a 64-week study at 53 sites across 10 countries.
Celgene inflammation and immunology president Terrie Curran 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.”