Sanofi/Regeneron and Amgen, Inc. will have applications heard for these new therapies on June 9th and 10th, respectively. Pfizer, Inc. has an PCSK9 inhibitor currently in Phase III clinical trials.
The Center for Drug Evaluation and Research, Endocrinologic and Metabolic Drugs Advisory Committee of the FDA will discuss the safety and efficacy of the Biologics License Applications (BLA) for PCSK9 inhibitors, as an adjunct to diet: on June 9 for alirocumab (Sanofi/Regeneron) “for long-term treatment of adult patients with primary hypercholesterolemia (non-familial and heterozygous familial) or mixed dyslipidemia including patients with type 2 diabetes mellitus…either in combination with a statin or as monotherapy including patients who cannot tolerate statins” and; June 10 for evolocumab (Amgen, Inc.) in “adults with hyperlipidemia or mixed dyslipidemia, either in combination with a statin or statin with other lipid lowering therapies (e.g. ezetimibe), or alone, or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or…for whom a statin is not considered clinically appropriate. In addition, the committee will discuss the safety and efficacy of evolocumab…in combination with other lipid-lowering therapies (e.g. statins, LDL apheresis) in patients at least 12 years of age with homozygous familial hypercholesterolemia.”
These hearings are open to the public and written submissions can be made before May 27, 2015. The FH Foundation will be there to represent the FH Community. If you have comments you would like us to share, or for more information, please contact Cat Davis Ahmed, Director of Outreach (email@example.com).
For more information on the meeting, CLICK HERE