New drugs promise to reduce heart disease complications
17 Mar 2015
New drugs produced by Amgen, Sanofi and Regeneron Pharmaceuticals for treating heart disease - the world's No 1 killer - are showing signs that they can reduce cardiovascular complications as they lower cholesterol levels.
Repatha, made by Amgen, and Praluent, under development by Sanofi and Regeneron, both cut cholesterol levels by more than 60 per cent, reveal studies published this Sunday in the New England Journal of Medicine.
The trials also showed patients getting the injected drugs were half as likely to die or suffer a major cardiac complication, such as a heart attack, stroke or chest pain, after just a year to 18 months of treatment.
While the findings aren't definitive, the results will make it easier for regulators to approve the drugs based on their cholesterol-lowering ability alone, Steve Nissen, chief of cardiology at the Cleveland Clinic in Ohio, who wasn't involved in the research, told Bloomberg News.
The results will also pressure insurance companies to pay for the treatments, which analysts expect to generate more than $2 billion a year in sales at their peak.
''It helps the companies developing these drugs to reassure the Food and Drug Administration that early approval based on cholesterol-lowering benefits is not a risky proposition,'' Nissen said.
The medications are the first of a new class called PCSK9 inhibitors that can lower cholesterol levels when statins such as Pfizer's Lipitor aren't enough.
Analysts expect the drug by Regeneron and Sanofi to reach the market first this year, with an FDA decision by July, followed by Amgen's treatment in August. Pfizer also has a drug in early stages of development.
