The US Food and Drug Administration has given the green light to Celgene Corp’s pill Otezla for moderate to severe plaque psoriasis.

The approval, which comes six months after the FDA approved Otezla (apremilast) for psoriatic arthritis, is primarily based on the ESTEEM studies, where treatment with the phosphodieasterase-4 (PDE-4) inhibitor resulted in improvements in plaque psoriasis as measured by PASI scores at week 16. Clinical improvement as measured by sPGA of clear to almost clear were also demonstrated.

Scott Smith, Celgene’s head of inflammation and immunology, added that Otezla “offers a valuable treatment option for a spectrum of plaque psoriasis patients...including those previously treated with biologic agents or conventional systemic agents”.

Many analysts believe that Otezla will be a blockbuster, despite competition from  the injectable tumour necrosis factor (TNF) inhibitors, notably AbbVie's Humira (adalimumab) and Pfizer/Amgen's Enbrel (etanercept). Shane Chapman at the Dartmouth-Hitchcock Medical Center, noted that “because the product labelling does not require routine laboratory monitoring, oral Otezla may be a welcome new option for patients and physicians looking for a different treatment experience”.

Otezla is also being studied for ankylosing spondylitis, but failed failed to hit its primary endpoint in a late-stage trial for the spine disease published in July.