Note: The following is an excerpt from a Reuters news article. Read the article in full here.
Pharmaceutical group Shire said on Sunday it had obtained a preliminary injunction in a Hamburg court against rival Roche聽over its hemophilia drug emicizumab, alleging incomplete and misleading statements surrounding the treatment.
Roche said in an emailed statement it would not comment on Shire’s statement but said it stood behind emicizumab data and its clinical trial protocol.聽Last month, Roche said emicizumab cut the bleed rate by 87 percent in patients with resistance to standard therapy compared with those who received another treatment.
Shire said in a statement the injunction sought 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.”聽At the time of last month’s announcement by Roche, analysts cited adverse events in Roche’s studies including thrombotic microangiopathy — damage to blood vessels in vital organs — that accompanied repeated high doses of bypassing agents given to counter bleeds that occurred despite emicizumab treatment.