FDA clears Merck & Co's combo diabetes/cholesterol therapy Juvisync

The US Food and Drug Administration on Friday approved the marketing of the first combination drug to treat type 2 diabetes and high cholesterol in one table- pharma giant Merck & Co’s Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both.

Sitagliptin is marketed under the name Januvia for the treatment of type 2 diabetes and generated 2010 revenues of $2.39 billion and $1.5 billion in the first half of this year, while the statin simvastatin is branded as Zocor, also once a blockbuster, but has been off patent since 2006, with sales last year of $468 million for Merck.

About 20 million people in the USA have type 2 diabetes, and they often have high cholesterol levels as well, said the FDA, noting that these conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, among other chronic conditions, particularly if left untreated or poorly treated.