FRANCHISE HERALD
Wednesday December 17, 2014

updated - December 17, 2014 Wednesday EST

FDA Warns of Cognitive Effects of New Cholesterol Drugs

Mar 08, 2014 01:44 PM EST | By John Nassivera
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FDA
FDA Warning of Cholesterol Drug Effects
The U.S. Food and Drug Administration has been looking into harmful effects that new cholesterol drugs have on cognitive function. Sanofi SA, one of the large drug firms developing the drugs, said in its annual report on Friday that the FDA asked them to evaluate the neurocognitive negative impacts of its drugs, one of which is called PCSK9 inhibitors.(Photo : USDAgov)

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The U.S. Food and Drug Administration has been looking into harmful effects that new cholesterol drugs have on cognitive function.

Sanofi SA, one of the large drug firms developing the drugs, said in its annual report on Friday that the FDA asked them to evaluate the neurocognitive negative impacts of its drugs, one of which is called PCSK9 inhibitors. Sanofi said the FDA made a similar request from Regeneron Inc., according to the Wall Street Journal.

The FDA said it could not give out specific details on development programs, Chicago Tribune reported. However, the company said it is "aware of concerns raised with neurocognitive adverse effects and other lipid-lowering therapies, including statins, and as part of our oversight of new drug development, we are carefully monitoring these events."

Regeneron Chief Executive Leonard Schleifer said in a phone interview on Friday that the FDA asked for the information from Regeneron and Sanofi in February, the Wall Street Journal reported. Dr. Schleifer said that neither company has been informed of such harmful effects or seen any signs of these effects in their clinical studies. Both companies are developing a drug called alirocumab, which is currently in late-stage clinical studies.

"We're not aware of any safety concern right now," Dr. Schleifer said.

Amgen Inc., another drug firm, said it also been contacted by the FDA and has been observing the development of their PCSK9 drugs for harmful effects, according to Chicago Tribune.

"Similar to other companies developing PCSK9 inhibitors, Amgen has been in communication with the FDA, and we will continue to investigate the potential for cognitive impairment in our program," Amgen said in an email.

Statins, approved treatments for high cholesterol, feature warnings of the potential for cognitive impairment, which include amnesia, confusion and memory loss, the Wall Street Journal reported. Dr. Schleifer said these may be the kind of effects that have the FDA concerned.

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