Sensing the probable side effects of cholesterol drug, Sanofi, the Food and Drug Administration (FDA) has asked Regeneron Pharmaceuticals Inc and Sanofi SA to assess the neurocognitive side effects of their experimental medicine.
FDA says, “The agency is aware of concerns raised with neurocognitive adverse events and other lipid-lowering therapies, including statins, and as part of our oversight of new drug development, we are carefully monitoring these events.”
Dr. Michael Aberman, Regeneron’s vice president for strategy and investor relations, says, “We have not seen a neurocognitive adverse signal in the alirocumab data. The alirocumab trials have been overseen by independent safety monitors.”
“What the FDA asked us to do we don’t expect to be difficult or time consuming,” Aberman added, he further stressed.
The new cholesterol drugs belong to an experimental class known as PCSK9 inhibitors. They are designed in such a manner so that it can block a protein that maintains “bad” LDL cholesterol in the bloodstream.
According to the Sanofi and Regeneron, the firm is completely confident that the drugs are safe as no such side effects were witnessed in alirocumab trials. The company says, they are clueless how the FDA learned of the potential side effects.
The FDA has issued similar advisory to another firm Amgen Inc, which is developing a similar drug.
“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 emailed statement.
The company said it has not seen any such signal so far.
The rare side effects of statins include memory loss, impaired concentration, and paranoia.