MDCO receives votes in favor of its blood clot preventer by FDA’s CRDAC
On Wednesday, MDCO announced that an independent advisory panel to the US Food and Drug Administration (FDA) has voted to recommend approval of company's intravenous blood clot preventer in angioplasty procedures.
The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9-2 to support the approval of investigational intravenous anti-platelet agent cangrelor for patients undergoing percutaneous coronary intervention (PCI), which is commonly known as angioplasty.
The PCI is performed to widen narrowed or clogged coronary arteries that often include the use of stents. The panel voted for cangrelor to reduce the risk of periprocedural thrombotic events such as myocardial infarction (MI), stent thrombosis (ST) and ischemia-driven revascularization.
The recommendation follows a review published by FDA staff on Monday, which supported the approval of the drug.
Cangrelor was approved by Europe in March, but was rejected by the FDA in April 2014. In its complete response letter, the agency had asked the drugmaker to reanalyze data from an important trial called Champion-Phoenix.
It was an 11,145 patient Phase 3 randomized, double-blind clinical trial comparing the Company's intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing PCI.
The CRDAC based its recommendation on the results of CHAMPION PHOENIX, which showed that cangrelor was more effective in lowering the risk of death, heart attack, repeat procedures and stent thrombosis 48 hours after angioplasty.
Although, the FDA is not obliged to follow the advice of its advisory panels but typically does so. According to the FDA's staff reviewers, the agency is expected to make its decision on cangrelor by June 23.
Loretta Itri, MD, Executive Vice President, Global Health Science and Regulatory, The Medicines Company said, "We are grateful for the recommendation of this Committee and appreciate the thorough review of our data for cangrelor. We look forward to continuing to work with the FDA in the coming weeks to bring this product to patients".