All pharma companies are looking to redirect some of the revenue in the cholesterol drugs market their way, but many find out access to such a huge income source is harder than what they originally imagined. Take for instance Merck, a huge name in the pharma business. The company’s latest proposal of a cholesterol drug combo has failed to impress the FDA, as regulators ask for more data.
Over the past few years diverse and numerous reporters have surfaced throughout the world regarding the health risks that cholesterol drugs carry. Recent reports warn that cholesterol drugs based on statins have been proved to feature a “small” risk of bringing along diabetes. As a result the Food and Drug Administration (FDA) has decided to add new safety warnings on the labels of such drugs.
But adding more safety precautions on labels isn’t the only thing the FDA has undertaken. The administration is paying increasingly more attention to the drug proposals companies bring to the table. They have proved several times, but perhaps dismissing Merck is evidence enough. The administration refused to give its approval for the company’s cholesterol drug and asked more data for a second investigation.
Merck’s new “miracle working” drug is actually a combo of two substances: ezetimibe (Zetia) and generic atorvastin found in Lipitor. The drug is known as ML-0653C and is an updated version of the not so successful ENHANCE trial, four years ago.
For Merck the stake is high. The company is trying to replace its current Vytorin with a much more efficient and successful drug that will bring along more revenue and bigger sales as opposed to its present version.
Vytorin became unsuccessful after Merck was forced by a congressional probe to publish the actual health effects of the drug. The results were so damaging they have immediately plummeted Vytorin sales. The probe showed that the much more expensive Vytorin wasn’t any more successful than Zocor, the cheap generic, in bringing down the level of plaque mass in neck arteries.
Basically, Merck’s new cholesterol combo remains an experimental drug that works in two ways to reduce health risks such as heart attacks.