European Medicines Agency backs Calliditas' setanaxib for Alport syndrome in positive COMP opinion.
NORDIC BUSINESS REPORT-October 5, 2023-European Medicines Agency backs Calliditas' setanaxib for Alport syndrome in positive COMP opinion
(C)2023 M2 COMMUNICATIONS http://www.m2.co.uk
Swedish commercial stage biopharmaceutical company Calliditas Therapeutics AB (Nasdaq:CALT) (STO:CALTX) said on Thursday that it has received a positive opinion from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome.
The COMP's decision will now undergo review by the European Commission, which is responsible for finalising the orphan designation and adding it to the Community register of orphan medicinal products for human use.
Orphan drugs are defined by the EMA as treatments for life-threatening or chronically debilitating rare conditions (affecting not more than five in 10,000 people in the EU) or those unlikely to generate sufficient profit for research and development. Orphan designation offers benefits such as protocol assistance and market exclusivity once marketing authorization has been granted by...
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