European Patent Office rules in favor of Sanofi and Regeneron concerning Praluent (alirocumab) - Seite 2
Sanofi possesses sole rights for Praluent outside the U.S. Regeneron has sole rights for Praluent inside the U.S.
Praluent is approved in more than 60 countries worldwide across the European Union (EU), North and South Americas, Asia, Africa and Australia.
In the European Union (EU), Praluent is approved for use in adults:
- with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet:
- in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
- with established atherosclerotic cardiovascular disease (ASCVD) to reduce cardiovascular (CV) risk by lowering LDL-C, as an adjunct to correction of other risk factors:
- in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
The effect of Praluent on CV morbidity and mortality has been recognized and approved by regulatory authorities in the EU, U.S., China and other international markets.
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