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Novo’s GLP-1RA Drugs Under EMA Review; Novartis’s Entresto Patent Ruled Invalid; FDA Approves Expanded Indication for Leqvio; Tonix Initiates Ph2 Intranasal TNX-1900 Study for Pediatric Obesity
Four cardiometabolic-related news items have been observed: Novo Nordisk’s diabetes and obesity drugs, Ozempic/Wegovy (semaglutide) and Saxenda (liraglutide), are under EMA review following two cases of suicidal ideation and one case of self-harm from users in Iceland (view article); Novartis announced the U.S. District Court for the District of Delaware ruled the patent covering Entresto and combinations of sacubitril and valsartan is invalid (view press release); Novartis also announced FDA approved a label update for Leqvio (inclisiran) to enable earlier use in patients with elevated LDL-C, as an adjunct to diet and statin therapy for patients who have not had a CV event but are at an increased risk for heart disease (view press release); and Tonix Pharmaceuticals announced the first participant has been enrolled in its Ph2 POWER study of TNX-1900, an intranasal potentiated oxytocin, for the treatment of pediatric obesity (view press release; CT.gov record). Below, FENIX provides highlights and insights into the respective news items.