Celgene announced Friday that the oral PDE4 inhibitor Otezla (apremilast) was approved by the FDA for adults with active psoriatic arthritis. The company said the drug, which is the first oral therapy for this indication in the US, will be launched this month through a network of specialty pharmacies.
Otezla's approval was supported by data from the late-stage PALACE 1, PALACE 2 and PALACE 3 studies, involving 1493 adults with active psoriatic arthritis inadequately controlled by disease-modifying anti-rheumatic drugs or biologics. Results demonstrated that patients treated with Otezla experienced improvement in signs and symptoms of psoriatic arthritis, compared with placebo.
As part of the approval, the FDA said Celgene must create an exposure registry as a post-marketing requirement to evaluate the risks of the treatment in pregnant women. Further, the agency said patients who take Otezla should have their weight regularly monitored by a healthcare professional, with treatment discontinuation considered for those who experience unexplained or clinically significant weight gain. The FDA also noted that Otezla was associated with more reports of depression, compared with placebo.
Celgene has said it estimates that Otezla could generate revenue of $1.5 billion to $2 billion by 2017. However, Sanford Bernstein's Geoffrey Porges, who projects sales of $800 million for the drug by 2019, indicated that "we're cautious about achievability of management's guidance for this product." The analyst added "it's a highly competitive category and there are a lot of drugs with greater efficacy."
Current treatments for psoriatic arthritis include injectable TNF blockers, such as AbbVie's Humira (adalimumab) and Johnson & Johnson's Remicade (infliximab), as well as corticosteroids and an interleukin-12/interleukin-23 inhibitor. Meanwhile, Cantor Fitzgerald analyst Mara Goldstein suggested "the psoriatic arthritis market will be a solid fit for Otezla given the dissatisfaction with current drugs," and that the therapy "has a good chance of widespread use."
Celgene is also developing Otezla for other indications, including psoriasis, with an FDA decision expected by September. Last June, the company reported positive mid-stage study data for the drug as a potential treatment for Behçet's disease.
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