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June 10, 2014
18:43 EDTBMYBristol-Myers: AVERT trial shows high rates of DAS-defined remission
Bristol-Myers Squibb announced its first release of new data from a Phase IIIb RA trial showing that the T-cell co-stimulation modulator, Orencia, in combination with methotrexate achieved significantly higher rates of DAS-defined (DAS28 CRP <2.6) remission at 12 months than treatment with standard of care agent MTX - 60.9% vs. 45.2%, respectively, in biologic and MTX-naïve patients with early active RA. The data are being presented this week at the 2014 annual meeting of the European League Against Rheumatism. In this trial, known as AVERT, a co-primary endpoint assessed maintenance of remission following the withdrawal of all RA drug therapy including Orencia, MTX and steroids. A small but statistically significantly higher number of patients treated with Orencia plus MTX, versus MTX alone, for 12 months maintained remission 6 months after all RA treatment was withdrawn. Orencia was well tolerated in the study patients. In particular, serious adverse events, serious infection events and discontinuation due to serious adverse events were comparable to patients treated with MTX. “These data demonstrating higher remission rates and a similar safety profile for Orencia plus methotrexate versus methotrexate alone, in conjunction with insights from the withdrawal phase of the study, support the use of Orencia as a first line biologic therapy for patients with RA,” said Michael Giordano, senior vice president, head of development, Oncology and Immunology, Bristol-Myers Squibb.
News For BMY From The Last 14 Days
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December 16, 2014
08:47 EDTBMYHemispherx Ampligen provides anti-tumor activity
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December 10, 2014
06:08 EDTBMYBristol-Myers partners with Ono Pharma and Kyowa Hakko Kirin for oncology trial
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December 9, 2014
16:35 EDTBMYBristol-Myers raises dividend to 37c per share from 36c per share
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08:25 EDTBMYBristol-Myers data positive, says BMO Capital
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December 8, 2014
13:32 EDTBMYPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
05:53 EDTBMYStocks with implied volatility movement; BSX BMY
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December 7, 2014
14:10 EDTBMYAmerican Society of Hematology to hold a meeting
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13:06 EDTBMYBMY announces positive results in Phase 1b trial evaluating Opdivo
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