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Shire Obtains Injunction Against Roche to Address Incomplete and Misleading Statements Regarding Investigational Agent Emicizumab That May Impact Patient Safety

Shire International GmbH has obtained a preliminary injunction in a court of Hamburg, Germany against F. Hoffmann-La Roche Ltd. (Roche) to address incomplete and misleading statements that may impact important issues of patient safety regarding the investigational treatment emicizumab.

Under the injunction, Shire seeks to prevent further dissemination of the inaccurate and misleading characterization of the serious adverse events that occurred in the HAVEN 1 Phase 3 trial of emicizumab, specifically the assertion that “all events occurred when repeated high aPCC (activated Prothrombin Complex Concentrate) doses were used concurrently with emicizumab.” The injunction also seeks to correct promotion of the primary data results relative to “treated bleeds” (a secondary endpoint) as compared to the primary endpoint of “number of bleeds over time” established at the outset of the trial.

Based on Roche’s publically available information to date (as of 7 July 2017), physicians, patients and caregivers may be misinformed about the appropriate management of breakthrough bleeds uncontrolled by emicizumab. In addition, through these actions, Shire believes Roche has unlawfully disparaged Shire’s proven bypassing agent, FEIBA (Anti-Inhibitor Coagulant Complex). Shire has issued multiple unheeded requests to Roche in an effort to resolve these concerns in an appropriate manner. As a result, Shire made the decision to seek court intervention.

Shire’s goal with this action is to ensure the hemophilia community receives sufficient, accurate information from Roche about the reported serious adverse events (SAEs) in the Phase 3 emicizumab trial, enabling physicians and their patients to make properly informed decisions about patient care.

As the global leader in rare hematology, Shire advocates in the interest of patient safety and continually defends the demonstrated 40-year safety profile of FEIBA.

The preliminary injunction is an interim measure which can be appealed by Roche.

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