U.S. Food And Drug Administration Approves ORENCIA® (abatacept) Supplemental Biologics License Application (sBLA) For Third-Party Manufacturing Facility Lonza Biologics Inc.
PRINCETON, NEW JERSEY (May 5, 2006) -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the licensure of Lonza Biologics Inc., a third-party manufacturing facility, to support increased production capacity for ORENCIA® (abatacept), enabling the company to meet expected long-term demand. This follows the December 23, 2005, FDA approval of ORENCIA, the first selective modulator of a co-stimulatory signal required for full T-cell activation, for the treatment of rheumatoid arthritis (RA).
ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.
ORENCIA became available for initial commercial use in February 2006. For more information about ORENCIA, healthcare providers and patients can call 1-800-ORENCIA® (673-6242) or visit www.ORENCIA.com.
Important Safety Information About ORENCIA®(abatacept)
Concurrent therapy with ORENCIA and a biologic DMARD is not recommended. In controlled clinical trials, patients receiving concomitant ORENCIA and TNF antagonist therapy experienced more infections (63 percent) and serious infections (4.4 percent) compared to patients treated with only TNF antagonists (43 percent and 0.8 percent, respectively), without an important enhancement of efficacy.
Caution should be exercised in patients with a history of infection or underlying conditions which predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and if positive, should be treated with standard medical practice prior to therapy with ORENCIA.
Less than 1 percent of patients treated with ORENCIA experienced hypersensitivity reactions, including two cases of anaphylaxis or anaphylactoid reactions. Other events potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in less than 0.9 percent of patients treated with ORENCIA and generally occurred within 24 hours of an infusion with ORENCIA. Appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.
Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation.
Chronic obstructive pulmonary disease (COPD) patients treated with ORENCIA developed adverse events more frequently than those treated with placebo (97 percent vs. 88 percent, respectively). Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to placebo-treated patients (43 percent vs. 24 percent, respectively), including COPD exacerbations, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to placebo-treated patients (27 percent vs. 6 percent), including COPD exacerbation (3 of 37 patients [8 percent] and pneumonia (1 of 37 patients [3 percent]). Use of ORENCIA in patients with rheumatoid arthritis and COPD should be undertaken with caution and such patients should be monitored for worsening of their respiratory status.
ORENCIA® (abatacept) should be used during pregnancy only if clearly needed. Rats treated every three days with abatacept during early gestation throughout the lactation period showed no adverse effects in the offspring at doses up to 45 mg/kg. At a dose of 200 mg/kg, alterations of immune function consisted of a 9-fold increase in the T-cell dependent antibody response in female pups and inflammation of the thyroid in one female out of 10 male and 10 female pups evaluated. Whether these findings indicate a risk for development of autoimmune diseases in humans exposed in utero to abatacept has not been determined.
Nursing mothers should discuss with their healthcare practitioner the risk/benefit of continued breast-feeding or discontinuation of the drug.
The most serious adverse reactions were serious infections (3 percent ORENCIA vs. 1.9 percent placebo) and malignancies (1.3 percent ORENCIA vs. 1.1 percent placebo).
The overall frequency of malignancies was similar in the patients treated with ORENCIA and placebo-treated patients. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2 percent) than placebo-treated patients (0 percent). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.
The most frequent adverse events occurring in greater than or equal 10 percent of patients treated with ORENCIA were headache, upper respiratory tract infection, nasopharyngitis, and nausea.
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