The European Medicines Agency’s advisory group CHMP has adopted a positive opinion backing approval of Esperion Therapeutics’ (NASDAQ:ESPR)
bempedoic acid, branded as Nilembo, for the treatment of adults with
primary hypercholesterolaemia (heterozygous familial and non-familial)
or mixed dyslipidemia. The applicant is FGK Representative Service GmbH (manages the regulatory filing process for companies without subsidiaries within the EU and Switzerland).
A final decision from the European Commission usually takes ~60 days.
https://seekingalpha.com/news/3536771-european-advisory-group-back-esperions-bempedoic-acid
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