The first non-injectable drug for psoriatic arthritis – Celgene’s Otezla – has been approved for marketing in the US and will be launched before the end of the month.
The orally-active phosphodiesterase 4 (PDE4) inhibitor has been given a green light by the FDA for use in adults with psoriatic arthritis, a debilitating auto-immune disease which combines inflammation and pain in the joints with the scaly skin lesions characteristic of psoriasis.
The approval of Otezla (apremilast) comes on the back of four phase 3 trials which showed that the drug was effective both as an initial therapy for new patients and for those who have been treated before with disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate and biologics such as AbbVie’s Humira (adalimumab) and Johnson & Johnson’s Remicade (infliximab).
The head of Celgene’s cellular therapeutics unit, Perry Karsen, said recently there may be up to a million patients with psoriatic arthritis in the US who are underserved and unsatisfied with existing medications and so may be candidates for Otezla therapy.
“The approval of oral Otezla is significant for patients living with psoriatic arthritis,” commented Dr Alvin Wells, director of the Rheumatology and Immunotherapy Centre in Wisconsin, US.
The new drug “offers physicians and patients a meaningful new treatment option, with the potential to benefit psoriatic arthritis patients irrespective of prior treatment”, he added.
Celgene has said it initially wants to position Otezla as a pre-biologic therapy, likely after initial treatment with methotrexate. As a condition of approval, the FDA has asked the firm to set up a registry of patients receiving the drug to evaluate the risks of the treatment in pregnant women, and has also asked it to monitor patients for sudden weight gain.
In addition to psoriatic arthritis, Celgene is also hoping to gain FDA approval of Otezla in psoriasis in the US later this year, adding another 2.5 million potential patients to its target population, and hopes for approval of both indications in the EU sometime in early 2015.
Apremilast is also in late-stage testing as a treatment for ankylosing spondylitis, inflammatory bowel disease (IBD) and atopic dermatitis.
Analysts’ predictions of the peak sales of the drug could be between $500m and $2bn a year, reflecting fairly wide variance on how well Otezla will fare in an increasingly competitive market for anti-inflammatory drugs.