Amgen's Repatha (evolocumab) Receives the US FDA's Approval for the Treatment of Heterozygous Familial Hypercholesterolemia
Shots:
- The approval is based on the P-IIIb HAUSER-RCT study evaluating the safety & efficacy of Repatha (420mg- SC) vs PBO in a ratio (2:1) in pediatric patients aged 10 - 17yrs. with HeFH for 24wks.
- The trial met its 1EPs i.e.- 38% reduction in LDL-C from baseline- patients treated with Repatha had improved secondary lipid parameters from baseline including (35% & 27%) reduction in non-HDL-C & total cholesterol along with 32% reduction in ApoB @24wks.- no new safety risks were observed
- Repatha is a mAb that inhibits PCSK9 & has been approved as an adjunct to diet & other LDL-C lowering therapies for HeFH. The therapy has previously been approved in patients aged ≥13 for the same indication
Ref: Amgen | Image: Amgen
Click here to read the full press release
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com