Alnylam's Overshadowed Givosiran Comes Into The Phase III Light
While attention has been focused on other products, Alnylam is set to take another RNAi product candidate – givosiran – into pivotal testing following positive early data in acute hepatic porphyria.
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Alnylam reported interim Phase III results that it believes support a filing for accelerated approval and a rapid market entry, but a US FDA decision may be delayed by up to six months to allow for a bigger dataset and complete safety assessment in acute hepatic porphyria.
Around three dozen key late-stage products could reach their first markets in 2019, according to a recent report from Informa Pharma's Biomedtracker. Company execs may need to plan for the disruptive potential of this group of new medicines on established markets and standards of care.
Although inotersen met efficacy endpoints in Phase III familial amyloidosis study, adverse event rates raised a red flag and give Alnylam's competing patisiran an edge on safety, at least for now.