FDA Requests Sanofi, Regeneron to Study Mental Side Effects of Cholesterol Drug

The U.S. Food and Drug Administration have requested the pharmaceutical companies Sanofi and Regeneron to study the mental side effects of its experimental cholesterol drug.

After discovering the adverse effects brought by the new generation of anti-cholesterol drugs, the federal agency has instructed the two pharmaceutical companies to investigate the drugs carefully.

The drug is chemically designed to inhibit the protein enzyme PCSK9, which is associated with high levels of low-density lipoprotein (LDL), or the "bad" cholesterol. It aims to help people who can't tolerate statin drug, which are the standard treatment, or can't control their cholesterol with other drugs.

Aside from that, the FDA told the companies to assess the feasibility of incorporating new tests that will check the possible cognitive effects into a group of patients during their late-stage trial of the drug, too.

"To date we haven't seen this problem but we're going to look for it carefully," said Regeneron Chief Executive Officer Len Schleifer in a phone call with Bloomberg Businessweek. "Right now this shouldn't change anything," with the timing to complete the trials.

According to an analyst with Deutsche Bank, Sanofi and Regeneron's experimental PCSK9 drug, alirocumab, may generate $2.5 billion in peak sales. Amgen's drug, evolocumab, on the other hand, may generate $1.96 billion.

Amgen Inc., another pharmaceutical company that is in the late-stage testing of the drug, said that it has communicated with the FDA and has been closely looking at patients in its clinical trials for possible cognitive side effects.

"We will continue to investigate the potential for cognitive impairment in our program," said Kristen Davis, a spokesperson for Amgen to Bloomberg Businessweek. "We do not anticipate any delay from this activity to our program."

In the meantime, it's still unclear if the request of the FDA will delay the approval of the drug in high-risk patient. High-risk patients may be younger individuals who are less likely to experience the neurocognitive and cognitive side effects.

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