Sanofi,s Praluent (Alirocumab) Received EU’s CHMP Positive Opinion
Shots:
- The Positive Opinion was adopted on Alirocumab on patients (n=153) with Heterozygous Familial Hypercholesterolemia
- The P-III study primary objective evaluate the safety & efficacy of Alirocumab that were every Q2W & every Q4W vs PBO for 24 wks., whereas the secondary objective includes effects on LDL-C levels, other lipid parameters & to evaluate safety & tolerability after open-label treatment, additionally analysis of anti-alirocumab antibodies
- Praluent, which comes in 2 dosages (75 mg & 150 mg), is the first and only PCSK9 inhibitor authorized in the US which blocks PCSK9 from binding to LDLR & decreases blood levels of LDL-Cl and increases the number of LDLRs available to remove LDL
Ref: European Medicines Agency | Image: Sanofi
*Note: This is not an original PR, this reference is taken based on European Medicines Agency website
Related News:- Sanofi and Regeneron Finalizes the Restructuring of Their Collaboration on Praluent (alirocumab)
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
