Celgene's Otezla approved in Europe for psoriasis
The European Commission (EC) has licensed Celgene's Otezla (apremilast) for the treatment of moderate-to-severe chronic plaque psoriasis and alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs) for active psoriatic arthritis.
The drug was approved last year by the US FDA in the same indications and marks another step forward in Celgene's strategic advance into the immunology sector.
The decision will been welcomed by patients as it fills a longstanding treatment gap, providing an effective formulation that can be taken orally and does not require regular monitoring, which is a benefit over tumour necrosis factor (TNF) blockers already in the field that are administered by injection and have been shown to increase infection levels.
Helen McAteer, chief executive of the Psoriasis Association commented that members had found current treatment options "unappealing owing to both experienced and potential side effects, or the way in which the treatment is administered. A new, convenient treatment has long been sought."
This is a significant week for European psoriasis patients, as Novartis has also gained EC approval for its first-in-class interleukin-17A inhibitor Cosentyx (secukinumab) in plaque psoriasis.
Otezla works by specifically targeting phosphodiesterase 4 (PDE4), which elevates intracellular cyclic adenosine monophosphate (cAMP) levels and helps to regulate the uncontrolled immune responses that cause the symptoms associated with psoriasis and psoriatic arthritis.
In clinical trials, it demonstrated significant improvements in psoriatic skin plaques at week 16 versus placebo, with one third of patients in the Otezla treated group achieving this primary endpoint. It also demonstrated benefits across multiple manifestations of psoriasis, including itch, nail and scalp involvement, and quality of life measures.
In patients with psoriatic arthritis, Otezla demonstrated significant improvements, with twice as many patients treated with Otezla achieving the primary endpoint versus placebo at week 16. In addition, improvements in number of swollen joints, number of painful/tender joints, dactylitis, enthesitis and physical function were seen.
Celgene will be competing in an increasingly crowded psoriasis marketplace against established brands, including Pfizer's Enbrel (etanercept) and Johnson and Johnson's Stelara (ustekinumab), plus Novartis and Amgen with their newer IL-17 candidates.
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