The Medicines Company believes its anti-blood clotting drug cangrelor will eventually gain FDA approval despite its recent rejection by agency advisors, CEO Clive Meanwell says.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee earlier this month voted 7-2 against approving the drug to reduce thrombotic cardiovascular events such as stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). The panel also voted unanimously against approving the drug to maintain P2Y12 (a protein involved in blood clotting) inhibition in certain patients at increased risk for thrombotic events when oral P2Y12 therapy is interrupted.
Advisors were unsure of the efficacy of the data and some also echoed serious concerns raised by an FDA reviewer that the trials conducted to support the drug’s approval were done unethically.
Meanwell said on an investors call Wednesday that he was surprised by the vote outcomes, but after further discussions with the FDA, the company feels confident it can effectively address all concerns raised by the advisory committee.
“We see this as but one of several important steps in the process of NDA review,” he added.
When asked during the call if The Medicines Company was considering another pivotal trial on cangrelor as recommended by the advisory committee, or what effect a negative outcome would have on the company’s business forecast, Meanwell said it was premature to discuss those issues.
The FDA action date for cangrelor is April 30, and the drug has also been accepted by the EMA for review. — Ferdous Al-Faruque
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