PRINCETON, N.J., Jan. 3 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company announced today that it has completed submission of the supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the licensure of a third-party manufacturing facility to support increased production capacity for ORENCIA(R) (abatacept). Bristol-Myers Squibb announced on December 23, 2005 that the FDA approved ORENCIA, the first selective modulator of a co-stimulatory signal required for full T-cell activation, for the treatment of rheumatoid arthritis (RA). At that time, the company stated that, in order to increase production capacity and meet expected long-term demand for ORENCIA, the company expected to submit a sBLA to the FDA for a third-party manufacturing facility shortly.
ORENCIA is indicated for reducing the signs and symptoms of RA, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate (MTX) or tumor necrosis factor (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 is expected to be available for initial commercial use by the end of February 2006. During the period prior to sBLA approval, a single distributor will be used. For more information, healthcare providers and patients can call 1-800-ORENCIA (673-6242) or visit http://www.orencia.com/.
Important Safety Information about ORENCIA
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.
Live vaccines should not be given concurrently with ORENCIA or within three months of its discontinuation.
Chronic obstructive pulmonary disease (COPD) patients treated with ORENCIA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. 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 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 versus 1.9 percent placebo) and malignancies (1.3 percent ORENCIA versus 1.1 percent placebo).
The overall frequency of malignancies was similar in 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 to 10 percent of patients treated with ORENCIA were headache, upper respiratory tract infection, nasopharyngitis, and nausea.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
Bristol-Myers Squibb Forward Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward- looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. There can be no guarantee that the sBLA referenced in this release will be accepted by the FDA for filing, and if accepted, will be approved. Forward- looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2004 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
