The Medicines Co.’s Post-Angioplasty Drug Kengreal Secures FDA Green Light

More than a year after being rejected by the FDA, The Medicines Company’s intravenous antiplatelet drug Kengreal has received the go-ahead as a post-angioplasty anticlotting agent.

The FDA passed on Kengreal (cangrelor) in April 2014 for two indications, angioplasty and bridging, claiming an increased risk of bleeding outweighed the drug’s benefits. The agency also cited a number of flaws in the drugmaker’s pivotal trial design, including poor choice of comparator and uncertainty about adverse events such as heart attack, which the firm only measured using cardiac biomarkers in patients’ blood.

The Medicines Company went back to the drawing board, resubmitting its NDA for the post-angioplasty indication only based on a new trial comparing Kengreal with Plavix (clopidogrel) in more than 11,000 patients.

In that trial, Kengreal significantly reduced the incidence of heart attack, as well as the need for stent thrombosis and other procedures to open arteries, the FDA says. The rate of serious bleeding was low, but more common with Kengreal than with Plavis — one in 170 patients versus one in 275. However, the study also suggested Kengreal would prevent one major heart attack in every 171 patients treated.

In April, FDA reviewers backed Kengreal’s use ahead of an advisory panel meeting, saying the benefit was small, but the risk was smaller.

This marks the end of a long, arduous journey for the Parsippany, N.J., drugmaker, which first licensed the drug from AstraZeneca in 2003. The Medicines Company expects Kengreal to be available nationwide in July. Analysts have suggested the drug could net the company $75 million annually in the U.S.

An ADP inhibitor, Kengreal works by preventing platelet buildup. Roughly 500,000 people undergo angioplasty every year, the FDA says. — Kellen Owings