Celgene’s psoriatic arthritis drug Otezla approved

A new oral treatment for psoriatic arthritis, Celgene’s Otezla, has been approved in the US.

Otezla (apremilast) is Celgene’s attempt to break into the immunology field currently dominated by the TNF blocker drugs, led by AbbVie’s Humira.

The oral treatment has a novel mechanism, reducing swelling in joints and improving physical function in sufferers by blocking the enzyme phosphodiesterase 4 (PDE4).

Celgene’s extensive trial programme showed the drug provided benefits comparable to those seen in patients taking TNF blocker drugs.

Otezla has a number of clear advantages over TNF blockers, the most obvious being its oral formulation, making it more convenient than the injections needed with TNF blockers. Significantly, Otezla also showed no sign of increased levels of infections or malignancies which have been observed in patients taking TNF blockers. This means Otezla will not carry a boxed warning, as TNF blockers do.

The FDA approval was based results from three large-scale trials – PALACE 1, 2 and 3 – in adults whose condition was inadequately controlled by disease-modifying anti-rheumatic drugs (DMARDs) and/or biologics. More than 75% of patients were previously treated with DMARDs only and 22% of patients were previously treated with biologics.

The drug represents an important point in Celgene’s strategy for growth, which until now has focused on one small field within oncology, myeloma. Otezla is one of three likely new blockbusters which the firm hopes will create new revenue streams worth billions. But breaking into the immunology field is particularly difficult, where the TNF blockers, led by AbbVie’s Humira are dominant.

Last year Celgene estimated peak annual sales of up to $1.75 billion in peak sales, but most analysts believe this is overly optimistic. However if Celgene is able to gain approval for use in psoriasis as well, this will boost its revenues.

The drug was filed in Europe in January this year, with a European approval launch anticipated therefore expected in the latter part of the year.

The other two drugs in the trio of potential blockbusters are Pomalidomide and Abraxane, and are both already approved. Pomalidomide is the firm’s next-generation multiple myeloma treatment, and has already been launched in the US and Europe. Abraxane, a novel reformulation of paclitaxel was approved in the US last year for late-stage pancreatic cancer, and is currently awaiting final EU clearance.

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