EMA gives positive opinion for Sobi's TRYNGOLZA for severe hypertriglyceridemia
What happened
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for TRYNGOLZA (olezarsen). The drug is recommended for treating adult patients with severe hypertriglyceridemia. This opinion is based on Phase 3 CORE and CORE2 studies, which showed a statistically significant reduction in triglyceride levels and acute pancreatitis events compared to placebo.
From prnewswire.com
Why it matters
If the European Commission confirms the decision, TRYNGOLZA would be the first RNA-targeted therapy authorized in the EU for severe hypertriglyceridemia. The positive opinion validates the drug's efficacy in treating this condition, which affects an estimated 700,000 people in the EU5.
From prnewswire.com
Who's involved
- sobiAnnounced the positive opinion for its drug TRYNGOLZA.
- European Medicines AgencyAdopted the positive opinion for the drug's indication extension.
- European CommissionIs expected to confirm the final market authorization decision.
- Ionis PharmaceuticalsSponsored the pivotal Phase 3 studies that supported the opinion.
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- sobiSpeculative
Sobi could see its market potential and revenue outlook increase following the positive regulatory action.
- Ionis PharmaceuticalsSpeculative
Ionis Pharmaceuticals may see its funding access and market price improve due to the validation of the Phase 3 studies it sponsored.
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The entities involved
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sobi
German beverage store chain
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European Medicines Agency
highest regulatory authority on medicines in the European Union
Nothing else this week.
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European Commission
executive branch of the European Union