Centocor's supplemental BLA for Remicade approved

By Elaine Rigoli

Tampa, Fla., June 21 - The Food and Drug Administration has accepted Centocor, Inc.'s filing of a supplemental Biologics License Application for Remicade (infliximab) for inhibiting the progression of structural damage and improving physical function in patients with active psoriatic arthritis (PsA).

The filing is based on one-year data from the double-blind, placebo-controlled trial known as Impact 2 and two-year data from the double-blind, placebo-controlled trial known as Impact.

PsA is a chronic, progressive and potentially debilitating disease that causes joint inflammation and is frequently associated with skin plaques of psoriasis, according to a news release.

"Findings from Impact 2 show that early intervention with Remicade therapy can significantly inhibit the progression of joint damage, which is an important factor in the long-term prognosis of patients with psoriatic arthritis. We are encouraged by these data and are pleased that the FDA has accepted the file for review," senior vice president of clinical research and development Jerome A. Boscia said in the release.

The company also said that Remicade-treated patients demonstrated significant improvement in physical function as measured by the Health Assessment Questionnaire, which assesses the difficulty a patient has accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and other activities of daily living).

As early as week 14, patients in the Remicade group experienced a median improvement of 43%, compared with zero percent in the placebo group; results were maintained through one year.

At week 54, there was a median 50% improvement in HAQ score from baseline in the group randomized to Remicade and a 46% improvement in the placebo patients who switched to Remicade.

At week 54, 59% of Remicade-randomized patients and 53% of placebo patients who crossed over to Remicade had improvement in HAQ by greater than or equal to 0.3 scores, indicating clinically meaningful improvement in physical function.

Malvern, Pa.-based Centocor, a wholly owned subsidiary of Johnson & Johnson, develops products to treat Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis and pediatric Crohn's disease.

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