Printer Friendly

United States : Bristol-Myers Squibbs ORENCIA (abatacept) Receives Second European Commission Approval in Less than a Year New Approval for Treatment of Active Psoriatic Arthritis (PsA)1.

Bristol-Myers Squibb Company announced today that the European Commission (EC) has approved ORENCIA alone or in combination with methotrexate for the treatment of active Psoriatic Arthritis (PsA) in adult patients for whom the response to previous disease-modifying antirheumatic drug (DMARD) therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required.

This approval, which allows for the expanded marketing of ORENCIA as a treatment for PsA in all 28 Member States of the EU, marks the second new indication for ORENCIA in less than a year; in September 2016, the European Commission approved ORENCIA, in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. PsA becomes the third autoimmune condition, along with rheumatoid arthritis and juvenile idiopathic arthritis, for which ORENCIA is approved to treat in Europe.

This EC approval builds on the well-established profile of ORENCIA in Rheumatoid Arthritis and exemplifies our commitment to ongoing clinical research of ORENCIA as a potential treatment for autoimmune conditions where treatment options are limited or where patients have not been helped enough by other medications, said Brian J. Gavin, Ph.D., Vice President, ORENCIA Development Lead at Bristol-Myers Squibb. Despite the current availability of medications, there are many people with active Psoriatic Arthritis who are in need of a new treatment option; the approval of ORENCIA now provides a novel immunotherapy approach that may help these patients.

The approval was based on results from two randomized, double-blind, placebo-controlled studies (Studies PSA-I and PSA-II) in which a higher proportion of patients achieved an ACR 20 response, the primary endpoint, after treatment with ORENCIA 10 mg/kg intravenous (IV) or 125 mg subcutaneous injection (SC) compared to placebo at Week 24: 47.5% versus 19.0% and 39.4% versus 22.3% (p ).

COPYRIGHT 2017 SyndiGate Media Inc.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2017 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:Mena Report
Date:Jul 27, 2017
Previous Article:Australia : New committee to review Australian Standards for the Export of Livestock.
Next Article:Australia : Commonwealth disaster assistance for Byron.

Terms of use | Privacy policy | Copyright © 2019 Farlex, Inc. | Feedback | For webmasters