Dec
20
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Novartis' ($NVS) bid to expand the use of Rasilez has run into serious trouble. The pharma company joined the lineup of Big Pharma companies reporting trial setbacks today with the news that unexpected side effects and disappointing efficacy results forced them to halt their development work. Novartis had hoped that Rasilez, sold as Tekturna in the U.S., could be used to guard organs. Investigators had recruited more than 8,000 patients in danger of organ failure for its studies. Report
Nov
28
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Swiss drug giant Novartis ($NVS) revealed Monday that it has a green light to market a combo pill in the European Union to patients who need multiple meds to control their high blood pressure. The European Commission gave approval to Rasitrio, which combines a trio of treatments that aid in improving the flow of blood through vessels.
It's the first drug in Europe that consists of Novartis' renin inhibitor Rasilez, the popular calcium channel blocker amlodipine and the diuretic hydrochlorothiazide, according to the company. The approval adds to Novartis' stable of combo drugs for high blood pressure, and the company says 85% of patients need more than one treatment to combat high blood pressure. But sometimes patients forget to take all their meds, making combo pills like Rasitrio a way to pack multiple drugs into one tablet and improve patient adherence. The FDA pinned an approval on the triple combo pill, marketed in the U.S. as Amturnide, last December.
On top of the convenience of a combo pill, Rasitrio beat dual combos of each of its three ingredients in a Phase III clinical trial of 1,181 patients with high blood pressure, according to Novartis. The study showed that the triple-combo drug's effects were seen in patients in as little as one week after starting treatment and each daily dose continued to perform in between the times patients took the pill.
"Simplification of treatment for high blood pressure patients on three or more therapies is key to improving patient compliance and outcomes," said Dr. Josep Redon, of Hospital Clinico, University of Valencia, Spain, in Novartis' release. "This innovative triple combination therapy, which has demonstrated significant reductions in blood pressure during clinical trials, offers patients a new and convenient treatment option."
- here's the release
- see The Economic Times article
- and the piece in the Pharma Times
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