A NOVEL DRUG APPROVED FOR PSORIASIS

(Reuters) - Celgene Corp's experimental oral drug apremilast proved to be more effective than a placebo for psoriasis patients in a late-stage study, clearing the way for the company to file for U.S. regulatory approval in the second half of 2013.

Celgene said 59% of patients in the 844-patient trial achieved a 50% improvement in symptoms at 16 weeks, using a standard score of the severity and extent of psoriasis, compared with 17% of placebo patients. A 75% improvement in symptoms was seen in 33% of the treatment group and 5% of the placebo group.

Apremilast inhibits phosphodiesterase 4, or PDE4, and acts to damp down inflammation.

The Phase 3 trial is the first of two pivotal studies of the drug in patients with psoriasis.

Celgene said previously it planned to file for Food and Drug Administration approval of the drug as a treatment for psoriatic arthritis in the first quarter of this year.

Side effects were consistent with those seen in earlier trials of the drug, with the most common being diarrhea and nausea.

Celgene said no cases of tuberculosis or lymphoma were observed through week 16, and there was no increase in risk of cardiovascular events or serious opportunistic infection.

"From a physician's perspective, this can definitely be a first-line therapy because of the excellent risk/benefit profile," said Dr. Richard Langley, director of dermatology research at Dalhousie University in Halifax, and one of the study's lead investigators. "I think the patient acceptance of this drug and the physician acceptance is going to be extremely high."

He noted that most psoriasis patients are currently treated with methotrexate, which can cause serious side effects.

Newer biologic drugs used to treat psoriasis, which include Amgen Inc's Enbrel (etanercept) and AbbVie Inc's Humira (adalimumab), can make patients more susceptible to infection, Dr. Langley said.