A little less than a year ago The Medicines Co. said its third late-stage trial of cangrelor managed to do something that the first two had failed at: Conclusively demonstrate the superiority of its blood thinner over Plavix. But today at least one reviewer at the FDA resoundingly rejected that assertion in an internal assessment of the drug, which concludes that none of the biotech's data demonstrate either superiority of noninferiority over the older drug, its drug may be harmful to some patients and shouldn't be approved based on what the agency has seen so far.
The internal review by Thomas Marciniak includes blistering criticism of the use of different doses of the two drugs in the study, that the studies included work which was done unethically and that another study is needed that could correct for all the flaws of the previous work.
But Reuters reports that another FDA reviewer, Fred Senatore, concluded that the company did present a convincing case that the drug met the main goal of the study, warranting an approval.
The internal agency assessments--a rare portrait of contrasting views--come two days before an advisory committee review of the data, promising to make for a rocky session while significantly lowering the odds for any kind of an approval anytime soon.
The biotech's shares ($MDCO) were down only about 6% by mid-morning, though, helped by an assessment from Leerink which concludes that the company doesn't have much to lose, even if the agency's comments were more critical than expected.
Back in March of 2013, The Medicines Co. painted a positive picture of its third late-stage study. In its assessment, their drug significantly reduced the risk of heart attack, a repeat procedure or stent thrombosis within 48 hours. And the biotech had invested heavily in the third study after spending an estimated $100 million for the first two.
The results last March encouraged some analysts to estimate that the biotech's cangrelor could earn up to $400 million a year.
- here's the FDA review
- here's the Reuters story