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Novo Nordisk acquires Akero Therapeutics to enhance its portfolio with efruxifermin, a promising treatment for metabolic dysfunction-associated steatohepatitis.
The deal includes Akero’s Phase III FGF21 analogue efruxifermin treatment for MASH.
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Novo Nordisk entered into a definitive agreement to acquire Akero Therapeutics, along with its fibroblast growth factor 21 (FGF21) analogue efruxifermin (EFX), which is a potential best-in-class treatment for metabolic dysfunction-associated steatohepatitis (MASH).Upwards of 40% of MASH patients having type 2 diabetes, with over 80% also being overweight or living with obesity. This acquisition reflects the company’s long-term strategy aiming to develop medicines to treat patients living with diabetes, obesity, and other associated comorbidities.1
“MASH destroys lives silently, and efruxifermin has the potential to change that by reversing liver damage,” said Mike Doustdar, president and CEO of Novo Nordisk. “If approved, we believe it could become a cornerstone therapy, alone or together with Wegovy (semaglutide), to tackle one of the fastest-growing metabolic diseases of our time. This acquisition embodies Novo Nordisk’s relentless ambition to move faster, go further, and ultimately deliver on our commitment to pursue leadership in diabetes, obesity and their associated comorbidities.”
According to the terms of the definitive agreement, Novo Nordisk will acquire all outstanding shares of Akero’s common stock for $54-per-share in cash at closing.1 Akero shareholders are also entitled to receive a non-transferable CVR giving shareholders the potential to receive an additional $6 per share in cash, following U.S. regulatory approval of EFX for compensated cirrhosis due to MASH. Both Akero and Novo Nordisk’s boards unanimously approved the transaction and is expected to be complete by the end of the year.
According to a press release from Novo Nordisk, the acquisition is not expected to impact Novo Nordisk’s operating profit outlook for 2025, but the free cash flow outlook for 2025 is expected to be negatively impacted by approximately $4 billion.1
EFX is currently undergoing evaluation in three phase III trials, and in previous phase II trials, EFX displayed the ability to reverse fibrosis, including compensated cirrhosis, resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile.1 In the Harmony and Symmetry phase II trials, EFX demonstrated a 49% and 29% reduction in fibrosis without worsening of MASH respectively, compared to a 19% and 11% reduction in groups administered with the placebo.1. EFX is the only treatment to show significant fibrosis regression in compensated cirrhosis patients in a phase II trial.
EFX holds the potential to address the complex, multi-system disease state of all stages of MASH, while also improving risk factors linked to cardiovascular disease, which is the leading cause of death among patients diagnosed with MASH.1 Additionally, EFX is designed for subcutaneous dosing once a week, along with being engineered to mirror the biological activity profile of native FGF21.1
“Efruxifermin complements Novo Nordisk’s leading portfolio and is aligned with our commitment to building a competitive portfolio of treatment options across the stages of MASH. Within MASH, there remains a huge medical need for effective treatment options, especially in the later stages of the disease,” said Martin Lange, chief scientific officer and executive vice president of research & development at Novo Nordisk. “Based on the data generated by Akero, we believe efruxifermin could be a first- and best-in-class treatment for mid- to late-stage MASH with the potential to reverse liver damage. Novo Nordisk is uniquely positioned to unlock the full potential of efruxifermin and reach more patients living with MASH.”
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