The US FDA approved enlicitide on July 16, a new once-daily 20 mg oral tablet that functions as a PCSK9 inhibitor to lower LDL cholesterol levels.
In the CORALreef Lipids trial involving 2,904 adults, the drug reduced LDL cholesterol by 56% against a placebo at 24 weeks, with a 59% reduction observed in patients with genetic hypercholesterolaemia.
While not yet available in India, the CDSCO granted approval on July 20 to conduct a local Phase 3 trial, potentially offering an alternative to existing injectable PCSK9 therapies.