This excerpt taken from the BMY 8-K filed Jan 28, 2010.
On January 20, the European Commission approved ORENCIA® in combination with methotrexate for the treatment of moderate to severe active
polyarticular juvenile idiopathic arthritis in pediatric patients six years of age and older who have had an insufficient response to other disease-modifying anti-rheumatic drugs, including at least one TNF inhibitor.
The company announced key ORENCIA data at the American College of Rheumatology annual scientific meeting:
New clinical safety data support continued development of a subcutaneous administration of ORENCIA for patients with moderate to severe rheumatoid
arthritis. A four month study showed that weekly administration of a 125 milligram subcutaneous dose of ORENCIA resulted in minimal, transient immunogenicity prior to month 4 after repeat dosing.
The results of the two-year AGREE study support the use of ORENCIA for methotrexate-naïve patients with moderate to severe rheumatoid arthritis,
of less or equal to two years duration. The data from the AGREE study show that taking ORENCIA in combination with methotrexate achieved sustained low disease activity scores at 24 months.
This excerpt taken from the BMY 8-K filed Oct 22, 2009.
The company announced on September 3 that the FDA had accepted, for filing and review, the companys submission of a biologic license
application for belatacept, which is in ongoing Phase III development for use in kidney transplantation. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is May 1, 2010.
On August 26, the company announced that clinical data added to the labeling for ORENCIA® support use of ORENCIA for patients with moderate to
severe rheumatoid arthritis of less than or equal to two years duration. The efficacy and safety data further support use of ORENCIA in new-to-biologic patients with moderate to severe rheumatoid arthritis.
This excerpt taken from the BMY 8-K filed Jul 23, 2009.
At the American Transplant Congress in May, the company presented the results of two Phase 3 trials for belatacept, an investigational co-stimulation blocker being
studied for use in solid organ transplantation. The data suggest that belatacept may represent a promising therapeutic option for kidney transplant patients.
Results of two studies that demonstrated the consistent safety and effectiveness of ORENCIA over 5 and 7 years of treatment in rheumatoid arthritis patients who
have had an inadequate response to methotrexate were presented in June at the European Congress of Rheumatology (EULAR).