Alirocumab LDL Cholesterol Lowering Drug May Be Harmful
The U.S. Food and Drug Administration (FDA) has asked France-based pharmaceutical company Sanofi and biopharmaceutical company Regeneron to re-examine the drug alirocumab.
It is possible that the drug produced by the two companies may cause negative neurological effects in patients.
FDA’s Concerns Regarding Alirocumab
Alirocumab is a human monoclonal antibody for proprotein convertase subtilisin/kexin type 9 (PCSK9). It is a PCSK9 inhibitor designed to lower cholesterol.
According to Forbes, if the drug is found to cause adverse effects, the entire class of drugs will be pushed aside. These concerns could result in delays in the approval of these medications. The conventional wisdom has been that the PCSK9 inhibitors will be able to gain approval before the completion of outcome studies.
The FDA’s concerns were first seen in annual reports published in February for Regeneron, and then in March for Sanofi.
Both companies claimed to not know the circumstances under which the FDA became aware of the adverse events or whether these adverse events were observed in participants treated with alirocumab only or in combination with a statin or other cholesterol-lowering agent.
The FDA has asked Sanofi and Regeneron to study the drug’s effects in long-term testing.
ODYSSEY-OUTCOMES is a large-scale clinical trial of alirocumab in patients who have experienced an acute coronary syndrome. The data collected in this study will be considered in determining the effects of the drug.
The companies Pfizer and Amgen are also working on PCSK9 inhibitors, known as bococizumab and evolocumab.
Additional Information on PCKS9 Inhibitors
Information provided by the National Center for Biotechnology Information (NCBI):
- In all findings published in 2012, phase I and II clinical trials demonstrate that fully human monoclonal antibodies targeting PCSK9 dramatically reduce LDL-Cholesterol, and enable patients to reach their target goals without severe or serious safety issues.
- LDL receptor inhibitor proprotein convertase subtilisin kexin type 9 (PCSK9) has emerged as a validated target for lowering plasma LDL cholesterol levels.
- The short-term efficacy, safety and tolerability of two monoclonal antibodies to PSCK9 have been demonstrated in several phase II trials. These PCSK9 inhibitors are now tested in larger phase III studies to provide insights into the long-term safety and clinical efficacy of this promising approach