Medicines Co.’s blood thinner was 22 percent more effective reducing heart risk after a stent procedure than Plavix, a study said, paving the way for the company to apply for U.S. regulatory clearance.
The drug, Cangrelor, may generate $400 million in sales by 2019, said Adnan Butt, an analyst with RBC Capital Markets in San Francisco, said before the results were announced.
Medicines Co. announced it was shelving Cangrelor in 2009 after earlier trials showed the therapy wasn’t more effective than other drugs. In January, the Parsippany, New Jersey-based company said it found in follow-up studies the therapy significantly outperformed Plavix, a blood thinner from Sanofi and Bristol-Myers Squibb Co., that has lost patent protection and is now in generic forms.
“The stronger the benefit and the safer the drug works, the better it will be both for clinical conversion and regulatory perspective,” Butt said in an interview before the data were released. “Anything above 20 percent is great.”
Today’s presentation, given at the American College of Cardiology meeting in San Francisco, detailed the results from the study announced in January.
The trial of 10,900 patients worldwide looked at the number of patients who died, had a heart attack, stent thrombosis or ischemia-driven revascularization 48 hours after receiving one of the medicines. About 4.7 percent of patients given Cangrelor had one of these incidences, compared with 5.9 percent of patients on Plavix. Both groups had similar, low rates of severe bleeding, an important safety measurement.
“These are endpoints we worry about a lot in interventional cardiology and cardiology in general,” Deepak Bhatt, chief of cardiology at VA Boston Healthcare System and trial investigator, said in a statement. “This drug has several advantages, and nothing out there right now has quite the same biological properties.”
Cangrelor is meant to be used in the hospital by patients who need urgent heart procedures. The treatment is given intravenously and acts quicker and dissipates faster than Plavix, a pill, so it benefits patients needing immediate surgical procedures, Butt said. These patients probably will still need to take medicines like Plavix once they leave the hospital.
“This is not replacing those drugs by any means,” Butt said. “If something goes wrong, those drugs are problematic in terms of being able to do surgery on these patients.”
Medicines Co. has said it plans to file for U.S. Food and Drug Administration approval in the second quarter.