Summary of Cancellation for NiaStase RT

The purpose of this Supplement to New Drug Submission (SNDS) was to seek expansion of NiaStase RT (eptacog alfa) for the treatment of severe postpartum hemorrhage (PPH) when uterotonics are insufficient to achieve hemostasis. Postpartum hemorrhage occurs when there is excessive bleeding after the birth of a baby. About 1 in 100 to 5 in 100 women have postpartum hemorrhage. It is more likely with a cesarian birth and most often happens after the placenta is delivered, but it can also happen later. Excessive blood loss can lead to a severe drop in blood pressure and possible shock and if not treated, death. The sponsor proposed in this SNDS that recombinant activated Factor VII (rFVIIa) in the form of NiaStase RT was effective for woman with PPH when uteronics had failed to stop bleeding.

The proposed new indication was sought based on results of data collected from the clinical development program proposed by the sponsor which includes:

• Trial NN7711-4816: therapeutic, prospective, randomized, controlled, multicenter and multidisciplinary phase IV study conducted in France and Switzerland (published in 2015).
• Study NN7711-4729: Retrospective, single-centre, non-interventional, cohort study (hospital of Bern -CH).
• Study NN7711-4733: Retrospective, multi-country, non-interventional cohort study conducted in (DK, UK, NL).
• Study NN7711-4731: Retrospective, non-interventional cohort (UniSeven registry).
• Study NN7711-4732: Retrospective, non-interventional cohort, study using data from the (ANZHR registry).
• Other literature data sources.

At the time of cancellation, the review by Health Canada was on-going and no decision or recommendations had been made. However, Health Canada had identified deficiencies. Specifically, Health Canada noted issues with the evidence that was available to support the revised indication. To address Health Canada's concerns, the sponsor has taken the decision to withdraw their submission “Supplement to a New Drug Submission for the sought PPH indication” without prejudice to re-file at a later date with additional data.

NiaStase RT is a marketed product so there is no impact on the SAP. There are also no consequences for patients accessing NiaStase RT via clinical trials based on this cancellation request.