Novo Nordisk Reports the US FDA’s Approval of Wegovy for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Shots: The US FDA has approved a label extension for Wegovy to treat noncirrhotic MASH in adults with mod. to adv. liver fibrosis (F2 to F3 fibrosis) in combination with a reduced calorie diet & increased physical activity; Application submitted to EMA & PMDA in Feb & May 2025, respectively Approval was based on Part…

ByRidhi RastogiAugust 18, 2025

Ionis Reveals Topline P-III (ESSENCE) Trial Data of Olezarsen for Moderate Hypertriglyceridemia

Shots: Ionis has reported topline P-III (ESSENCE) trial data assessing olezarsen (50mg: 276 pts or 80mg: 832 pts, SC, Q4W for 12mos.) vs PBO (n= 369) in 1,478 adults with mod. hypertriglyceridemia (fasting TG ≥150mg/dL to <500mg/dL) with or at risk of ASCVD Trial met its 1EP with significant PBO-adjusted TG reductions of 61% (80mg)…

ByRidhi RastogiMay 19, 2025

Ionis Partners with Sobi for Olezarsen to Treat Familial Chylomicronemia Syndrome (FCS) & Severely Elevated Triglycerides

Shots: Ionis has granted Sobi global exclusive rights of olezarsen excl. the US, Canada & China to treat familial chylomicronemia syndrome (FCS) & severely elevated triglycerides; Ionis to independently market Olezarsen in the US, whereas Theratechnologies holds the rights in Canada As per the deal, Ionis will get an upfront, with potential milestone payments &…

ByRidhi RastogiMarch 27, 2025

Novo Nordisk Reports the US FDA’s Approval of Wegovy for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Ionis Reveals Topline P-III (ESSENCE) Trial Data of Olezarsen for Moderate Hypertriglyceridemia

Ionis Partners with Sobi for Olezarsen to Treat Familial Chylomicronemia Syndrome (FCS) & Severely Elevated Triglycerides

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