Ultragenyx Receives European Commission Decision For Evkeeza Expanded Indication In Children Aged 5 Years And Older With Homozygous Familial Hypercholesterolemia
Portfolio Pulse from Benzinga Newsdesk
Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) announced the European Commission's approval of Evkeeza for children aged 5+ with homozygous familial hypercholesterolemia (HoFH). The approval is based on a Phase 3 study showing a 48% reduction in LDL-C levels at week 24. Evkeeza is now available in the U.S., Canada, Italy, Germany, and through early access in Austria and France. The treatment is the first ANGPTL3 inhibitor for children as young as 5 to control high LDL-C levels due to HoFH.
December 18, 2023 | 1:08 pm
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Ultragenyx's Evkeeza received EU approval for an expanded indication to treat children with HoFH, potentially increasing the drug's market and boosting revenues.
The European Commission's approval for Evkeeza to treat a younger patient population could lead to increased usage and sales, positively impacting Ultragenyx's revenue in the short term. The news is directly related to Ultragenyx and its product, hence the high relevance and importance. The confidence score reflects the clear connection between regulatory approval and potential revenue growth.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100