FDA progress for Bayer’s new long-lasting factor viii with PEGylation (BAY94–9027)

Bayer announced last week they had submitted a Biologics License Application (BLA) with the FDA for their new long-lasting recombinant factor viii product called BAY94–9027 (damoctacog alfa pegol).

This product involves PEGylation with the goal of increasing the half-life and thus the amount of time between factor viii treatments.

PEGylation involves attaching a polyethylenglycol (PEG) molecule to a specific site on the factor viii protein and is an established technology for increasing the half-life for many other treatments as well. According to the NIH (2015 source), over 10 PEGylated drugs have been approved by the FDA to date with over 20 drugs in clinical trials including four long-acting hemophilia drugs.

Bayer completed a phase 1 trial of BAY94–9027 with 14 people with hemophilia a, a phase 2/3 trial with 134 people, and is now completing a phase 3 trial of 132 people. The results so far show a half-life of about 19 hours and a likely dosing schedule of twice weekly. Significantly, this new version of the factor viii protein does not appear to cause inhibitors.

Bayer hopes with BAY94–9027 to continue their long experience with recombinant factor viii products including Kogenate (over 25 years since approval) and more recent product Kovaltry.

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