Novo Nordisk will acquire Akero Therapeutics for USD 4.7 billion cash plus USD 500 million contingent value right tied to regulatory approval of efruxifermin in metabolic dysfunction-associated steatohepatitis (MASH) with compensated cirrhosis. The weekly subcutaneous FGF21 analogue demonstrated 49% fibrosis improvement in the Phase IIb HARMONY trial for F2-F3 patients and 29% reduction in the SYMMETRY study for F4 cirrhosis, with 19% and 11% MASH resolution rates respectively at 96 weeks. Efruxifermin represents a potential best-in-class therapy addressing multiorgan metabolic dysfunction through improved insulin sensitivity and lipoprotein profiles.

The global Phase III SYNCHRONY programme enrols 3,500 patients across histological, outcomes and real-world evidence studies targeting pre-cirrhotic and compensated cirrhotic MASH populations. Over 40% of MASH patients have comorbid type two diabetes (T2D), with 80% meeting overweight or obesity criteria aligning with Novo's metabolic disease expertise. CEO Mike Doustdar highlighted the potential for efruxifermin as cornerstone therapy alone or combined with semaglutide, addressing this progressive liver disease affecting over 250 million people globally with limited treatment options.

According to PharmCube's NextBiopharm® database, efruxifermin was leading the FGF21 analogue pack until Roche's pegozafermin beat it to late-stage in 2023. Click here to request a free trial for NextBiopharm®.