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May 23, 2014
09:15 EDTPFEPfizer says tofacitinib met two primary efficacy endpoints in Phase 3 study
Pfizer announced detailed results from the Oral treatment Psoriasis Trial Retreatment study, a Phase 3 study investigating tofacitinib for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. This three-period study showed that tofacitinib, as a 5 mg or 10 mg pill taken twice daily, met its two primary efficacy endpoints. The safety profile of tofacitinib in OPT Retreatment was consistent with previous studies and there were no new safety findings in this trial. The first primary endpoint of OPT Retreatment evaluated the maintenance of clinical response in patients who remained on tofacitinib after an initial treatment phase compared to patients who were switched to placebo. The second primary endpoint examined patients who lost half of their original clinical response during the withdrawal phase, and measured the proportion of these patients who regained their original clinical response after restarting treatment with tofacitinib. Throughout the study, the efficacy response was measured by the proportion of subjects achieving a Physician’s Global Assessment response of “clear” or “almost clear” skin and the proportion of subjects achieving at least a 75% reduction in the Psoriasis Area and Severity Index, two commonly used measures of efficacy in psoriasis.
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July 22, 2014
16:18 EDTPFEPuma Biotech now responsible for R&D expenses associated with legacy trials
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July 17, 2014
08:08 EDTPFEBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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July 16, 2014
10:36 EDTPFETreasury calls on Congress to halt inversion deals
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09:27 EDTPFEPfizer to acquire InnoPharma for upfront cash payment of $225M
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07:59 EDTPFETreasury Secretary urges Congress to take action on tax inversions
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07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
July 9, 2014
06:49 EDTPFEPfizer given dismissal of U.S. investor class action before trial, Reuters says
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