New Research to be Presented
In just a few days the American College of Cardiology will host their 68th Annual Scientific Session (ACC.19). It will be held in New Orleans, Louisiana March 16th through 18th.
You can read more about this upcoming event here.
The conference will highlight nine presentations from Amgen including results from the TAUSSIG trial which was the longest and largest open label study examining any potential treatment for homozygous familial hypercholesterolemia (HoFH) to date.
TAUSSIG
TAUSSIG stands for Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects wIth Genetic LDL Disorders. It is a part of Amgen’s PROFICIO program which consists of 36 different clinical trials examining Repatha’s affect on LDL-C levels and cardiovascular disease for a wide array of conditions. To date, the PROFICIO program has included more than 38,000 patients.
TAUSSIG was an open label study designed to examine the safety and efficacy of Repatha in patients with homozygous FH or heterozygous FH. Specifically, it evaluated the lipid-lowering efficacy of the drug as well as it’s long-term safety. The primary endpoint of the study was the incidence of adverse events. The secondary endpoints examined changes in LDL-C levels.
Repatha is a monoclonal antibody that works by inhibiting PCSK9. Ultimately it helps to increase the amount of LDLRs, which lowers the levels of LDL-C. Repatha is already approved in over 60 countries including the United States, Canada, Japan, and the European Union.
Patients in the FH study were given 420mg of Repatha each month (or biweekly if they were also on a lipoprotein apheresis). After the 12 week mark, all patients were able to receive the drug every two weeks. No patients in the study were under the age of 13, so the examination of this drug in the pediatric population is still an area which necessitates further research.
Results
Stay tuned to hear the full results from the TAUSSIG study as they are presented at the ACC.19 conference. However, know that ultimately this study reinforced the continued development of Repatha for HoFH.
There were few adverse reactions to Repatha in HoFH patients. The events that did occur in at least two patients were influenza, gastroenteritis, nasophryngitis, and upper respiratory tract infection.
Other good news includes that Amgen recently lowered the price of Repatha by 60%. It now costs $5,850 each year. This reduction was an effort by Amgen to improve the affordability of the treatment for all patients who are in need.
You can read more about the TAUSSIG trial and the upcoming conference in New Orleans here.
