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Ultragenyx Reports the EC’s Approval of Evkeeza (evinacumab) to Treat 6-Months Old Children with Homozygous Familial Hypercholesterolemia (HoFH)

Shots: The EC has approved Evkeeza (an angiopoietin-like 3 inhibitor), as an adjunct to diet & other lipid-lowering therapies, to treat children (6mos. to 5yrs.) with HoFH Approval was based on model-based analysis that predicted similar or greater LDL-C reductions with Evkeeza (15mg/kg, Q4W) in children (6mos. to 5yrs.) at 24wks. Data from compassionate…
January 6, 2025

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Insights+: EMA Marketing Authorization of New Drugs in December 2023
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in December 2023

Shots:  The EMA approved 3 BLA while 4 New Chemical Entities in December 2023, leading to treatments for patients and advances in the healthcare industry In December 2023, the major highlighted drugs were Jempreli to treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer and Zilbrysq for the treatment of Generalized Myasthenia Gravis   PharmaShots has compiled a list of a…
January 23, 2024

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VIEWPOINTS_Boaz Hirshberg_2023
VIEWPOINTS

Boaz Hirshberg, SVP, Clinical Development at Regeneron Shares Insights from the US FDA Approval of Evkeeza (evinacumab-dgnb)

Shots: Boaz spoke about the US FDA approval of Evkeeza (evinacumab-dgnb) to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH) Boaz also talked about the study design of the pivotal pediatric trial evaluating Evkeeza(evinacumab-dgnb) . He then extended his talk on HoFH and how Regeneron is creating awareness about the disease The…
July 31, 2023

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