Cangrelor Earns CHMP Recommendation for Use in PCI

Disclosures

January 23, 2015

LONDON, UK — A European agency has recommended approval of cangrelor (Kengrexal, the Medicines Company), an intravenous platelet P2Y12 inhibitor, for reducing thrombotic cardiovascular risk in adults undergoing PCI[1]. The recommended indication excludes its use in patients who have taken an oral P2Y12 inhibitor prior to the procedure.

The good news for cangrelor, announced by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), comes about a year after a US Food and Drug Administration (FDA) advisory panel voted decisively against approving the drug for the same indication. The panel had considered two major cangrelor trials that had to be stopped early for showing no likelihood of benefit (CHAMPION-PCI and CHAMPION-PLATFORM) and one positive trial (CHAMPION-PHOENIX). Ultimately, the FDA panel decided that the drug's risk/benefit profile wasn't favorable enough to recommend approval.

The EMA isn't obliged to but usually approves agents that the CHMP recommends for practice.

Cangrelor is "an immediately bioavailable and quickly reversible intravenous small-molecule antiplatelet agent" yet to be approved anywhere for any indication, notes the Medicines Company in a statement on the CHMP recommendation[2].

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