19 November 2024
19 November 2024
Tirzepatide is a long-acting dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist.
The approval is based on the Phase I/II AUGMENT-101 trial, which included 104 patients with acute leukaemia.
The CF Foundation's investment will propel the development of up to three gene correction programmes.
The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.
AstraZeneca will advance preclinical and clinical development of the type 1 diabetes cell therapy candidate.
Intellia presented data from its Phase I study of NTLA-2001 at the 2024 American Heart Association scientific meeting in Chicago.
CHMP's positive opinion was influenced by outcomes from the Phase III LAURA study.
The study confirmed that Afqlir has equivalent efficacy and comparable safety to its reference medicine, Eylea.
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