Astrazeneca PLC Sponsored ADR (AZN.US) AZD0780 film-coated tablets granted clinical approval in China, intended for the treatment of blood lipid abnormalities.
On September 11th, the official website of China's National Medical Products Administration Drug Evaluation Center (CDE) announced that AstraZeneca's AZD0780 film-coated tablet has obtained clinical trial implicit approval and is intended for the treatment of lipid abnormalities in patients with low-density lipoprotein cholesterol (LDL-C) levels that do not meet standards on the basis of standard therapy.
On September 11th, the official website of the China National Medical Products Administration Drug Evaluation Center (CDE) announced that Astrazeneca PLC Sponsored ADR (AZN.US) (AstraZeneca) AZD0780 film-coated tablets obtained clinical trial implied approval, intended for the treatment of blood lipid abnormalities in patients with low-density lipoprotein cholesterol (LDL-C) levels that do not meet the standard treatment.
Public information shows that AZD0780 is an oral PCSK9 small molecule inhibitor. According to the Phase 1 clinical trial data released by Astrazeneca PLC Sponsored ADR in May of this year, when AZD0780 is used in combination with the statin drug rosuvastatin, it can reduce LDL-C levels in patients by nearly 80%. This product is currently in Phase 2 clinical trials internationally, and this is the first time the product has been approved for clinical trials in China.
Analysis shows that in untreated patients with high cholesterol levels, AZD0780, when used in combination with rosuvastatin treatment, shows a significant decrease of 52% in LDL-C levels compared to baseline, with an overall decrease of 78% in LDL-C levels. Additionally, preliminary data comparing the administration of AZD0780 with food and on an empty stomach indicate that AZD0780 has flexibility in terms of administration with food. AZD0780 also demonstrates good tolerability.
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