Regulators in Europe have given the green light to Celgene Corp’s pill Otezla for psoriasis and psoriatic arthritis.

Specifically, the European Commission has granted marketing authorisation for Otezla (apremilast) for moderate-to-severe chronic plaque psoriasis in adults who have failed to respond to systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). It has also given the thumbs-up to the phosphodiesterase-4 (PDE-4) inhibitor for PsA in adults who fail on non-biological disease-modifying antirheumatic drugs.

Many observers believe Otezla will be a blockbuster, despite fierce competition from  the injectable tumour necrosis factor (TNF) inhibitors, notably AbbVie's Humira (adalimumab) and Pfizer/Amgen's Enbrel (etanercept). As well as being a pill, the Celgene drug does not require routine laboratory monitoring and is well tolerated.

Otezla was approved on March and September last year by the US Food and Drug Administration for PsA and psoriasis respectively. A positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in November and will be launched in the European Union in the coming months.

At the JP Morgan Healthcare Conference in San Francisco this week, Celgene chief executive Bob Hugin estimated that sales will pass the $20 billion mark  by 2020 and should rise 22% next year to $9-$9.5 billion. Otezla is expected to play a big part in those goals being reached.