European Commission approves Otezla for psoriasis, psoriatic arthritis

Celgene announced it has received European Commission marketing authorization for Otezla in treating moderate-to-severe chronic plaque psoriasis and psoriatic arthritis in adults.

Otezla (apremilast), an oral selective inhibitor of phosprodiesterase 4, is indicated for treating moderate-to-severe chronic plaque psoriasis in patients who have failed to respond to, have a contraindication to or are intolerant to other systemic therapies including cyclosporine, methotrexate or ultraviolet-A light, according to a press release. The drug also is indicated as treatment alone or in combination with disease modifying antirheumatic drugs (DMARDs) for treating active psoriatic arthritis (PsA) in adults who have experienced inadequate response or have been unable to tolerate DMARD therapy.

The marketing approval is based on efficacy and safety results from two phase 3 studies of apremilast in patients with psoriasis or PsA during a 52-week period.

In the ESTEEM studies, the primary endpoint was met when significant and clinically meaningful improvements in plaque psoriasis, or a 75% improvement in Psoriasis Area Severity Index scores, were achieved, according to the release.

The primary endpoint also was met in the PALACE study, which assessed improvements in the signs and symptoms of PsA as measured by a 20% improvement in the American College of Rheumatology disease activity criteria at week 16.

Adverse reactions reported were diarrhea, nausea, upper respiratory tract infection, tension headache and headache.

In accordance to local requirements, apremilast will be launched in the European Union in the months ahead, according to the release.

Apremilast was approved on March 21, 2014, by the FDA for the treatment of adults with active PsA and on Sept. 23, 2014, for treating patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, according to the release.

Reference: www.celgene.com.