Swiss drug manufacturer Novartis received unexpected good news. The U.S. Food and Drug Administration (FDA) has approved a new heart failure drug earlier than anticipated. The drug is called Entresto (generic names sacubitril or valsartan). The drug is designed for patients with heart failure caused by reduced ejection fraction (this is an assessment of how well the heart pumps following heart attacks or cases of high blood pressure.)
Approval has been through a special FDA fast-track process, granted where there is urgent clinical need. Speaking with PharmaFile, David Epstein, a spokesperson for Novartis pharmaceuticals, said: “As a result millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital. We recognize our responsibility to ensure Entresto reaches U.S. patients and prescribers as soon as possible and will begin shipping in the US in the coming week.”
There has been less good news for the U.S. company Vitae Pharma and the German multinational Boehringer Ingelheim. A final phase clinical trial of a diabetes treatment coded BI187004/VTP-34072, in combination with metformin, did not succeed in reducing blood sugar levels to the required threshold. Based on the results, the drug likely to be abandoned, industry magazine PharmaFile reports.
In other pharmaceutical sector news, PharamTimes reports that the company Pfizer has reached an agreement with the U.K. government over research. This is through the government agency, the National Institute for Health Research Clinical Research Network. This will be via Pfizer’s INSPIRE (Investigator Networks, Site Partnerships and Infrastructure for Research Excellence) program. Research centers will be set up in Manchester, Newcastle, Scotland and south west England.
