U.S. regulators have issued a complete response letter to Merck (NYSE:MRK), which delays the approval of its new drug application for ezetimibe and atorvastatin tablets, an investigational combination medicine.
According to a statement from the pharmaceutical giant, the U.S. Food and Drug Administration said additional data was needed, an issue the company said it will discuss when the results of two clinical trials become available later this year.
The combination of ezetimibe and atorvastatin is designed to replace the Whitehouse Station, New Jersey company’s high cholesterol drug Vytorin. Although its patent for Vytorin is not scheduled to expire until 2014, several companies are producing drugs for high cholesterol. Sales of Vytorin fell 16 percent in the fourth quarter to $475 million in 2011 compared with the same period in the previous year. Sales for the 12 months to Dec. 31 were $1.88 billion.
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A Merck spokeswoman said the letter was not prompted by the regulators new warning label advising that taking statins, which are designed to treat high cholesterol, could result in diabetes and memory loss.
Several Big Pharma companies are facing a patent cliff in the next couple of years as patents for blockbuster drugs expire and the lag to replace them with other lucrative drugs depends on uncertain regulatory time lines.