Ortho ImmunTec Announces FDA Approval of ORENCIA® (abatacept) for the Treatment of Adults with Moderate to Severe Chronic Plaque Psoriasis

Summary:

The U.S. Food and Drug Administration (FDA) has approved ORENCIA® (abatacept) for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. ORENCIA® is a selective co-stimulation modulator that selectively inhibits the activation of T cells, which are involved in the inflammatory process of psoriasis.

Efficacy and Safety:

The approval was based on the results of two Phase 3 clinical trials, in which ORENCIA® met its primary endpoints of achieving a reduction in the Psoriasis Area and Severity Index (PASI 75) and improvement in the Physician's Global Assessment (PGA) of clear or almost clear skin at week 12. The safety profile of ORENCIA® was consistent with previous studies, with the most common adverse events being injection site reactions, upper respiratory tract infections, and headache.

Mechanism of Action:

ORENCIA® is a fully human monoclonal antibody that selectively inhibits the co-stimulation of T cells by binding to CD80 and CD86, which are expressed on antigen-presenting cells. By blocking this co-stimulation, ORENCIA® modulates the immune response and reduces inflammation associated with psoriasis.

Clinical Importance:

The approval of ORENCIA® provides a new treatment option for adults with moderate-to-severe chronic plaque psoriasis, a debilitating condition that can significantly impact quality of life. ORENCIA® has been shown to be effective in reducing disease severity and improving skin clearance, offering hope to patients who have not responded to other therapies.

Availability:

ORENCIA® is available as a subcutaneous injection in prefilled single-use pens or vials. The recommended dosing regimen for psoriasis is 125 mg administered subcutaneously every other week.

Additional Information:

For more information about ORENCIA® and its use in the treatment of psoriasis, please visit the official website or consult with a healthcare professional.

Ortho Immun