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8 March

FDA delays action on Lilly’s donanemab, intent on advisory committee meeting

Credit: SewCreamStudio/

The US Food and Drug Administration (FDA) announced that it will delay action to convene an advisory committee to better understand the safety and efficacy of Eli Lilly’s investigational Alzheimer’s disease treatment donanemab.

Initially, the FDA planned to take action in Q1 2024. However, as per an 8 March press release, Lilly shared that the FDA Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) will assemble at a future date to discuss the Phase III TRAILBLAZER-ALZ 2 (NCT04437511) study that evaluated donanemab in patients aged 60-85 years with early symptomatic Alzheimer’s.

Aside from reviewing safety and efficacy, the committee is looking to answer questions about the study design, the decision to end treatment based on amyloid plaque assessment, and the enrollment of patients based on tau levels. Higher tau levels are correlated with a more advanced stage of the disease.

Previously, Eli Lilly also failed to gain an FDA accelerated approval for the treatment in January 2023.

1 March

FDA lifts two-year clinical hold on CytoDyn’s HIV trial

The FDA has lifted the clinical hold on Cytodyn’s leronlimab, allowing the company to evaluate the therapy as a treatment for human immunodeficiency virus (HIV).

Following the FDA decision, the US-based company’s stock was up by 62.5% at the market close on 29 February, compared to the market close on the previous day.

Leronlimab’s development has been tumultuous. The FDA first placed a partial clinical hold on the drug’s HIV programme and a full clinical hold on the Covid-19 programme in the US in March 2022. The company did not provide an update on the reasons behind the hold.

According to a November 2023 letter to shareholders, CytoDyn had to make ‘significant reductions’ to its workforce, cash burn rate, and operating expenses. 

Leronlimab is an experimental humanised immunoglobulin G4 monoclonal antibody that targets C-C chemokine receptor type 5 (CCR5). CytoDyn is also evaluating leronlimab as a treatment for Covid-19, glioblastoma multiforme (GBM), and non-alcoholic steatohepatitis (NASH).

6 March

FDA approves Sandoz’s two denosumab biosimilars

The US Food and Drug Administration (FDA) has approved Sandoz’s Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), marking the introduction of the first FDA-approved denosumab biosimilars. 

These biosimilars are authorised to treat all indications of their reference medicines. 

Wyost is indicated as interchangeable with its reference medicine, a human monoclonal antibody that acts on the RANKL protein, which is essential for the activation of osteoclasts. 

This approval positions Wyost as a treatment to prevent skeletal-related events in patients with multiple myeloma and for those with bone metastases caused by solid tumours. Wyost is also sanctioned for use in adults and skeletally mature adolescents with giant cell tumours in bone that are either unresectable or where surgical resection could cause significant morbidity.

Jubbonti is approved for treating high fracture risk in postmenopausal women with osteoporosis, for improving bone mass in men with osteoporosis at similar risk, and for managing glucocorticoid-induced osteoporosis in anyone with this risk. 

8 March

Johnson & Johnson acquires Ambrx Biopharma for $2bn

Johnson & Johnson (J&J) has concluded the acquisition of clinical-stage biopharmaceutical company Ambrx Biopharma in a $2bn transaction. 

The companies entered a definitive agreement to execute the acquisition in January 2024. The acquisition will be deemed a business combination and marks a significant step for J&J in enhancing its oncology portfolio, particularly in the area of prostate cancer. The strategic move will also strengthen the company’s capabilities in developing next-generation antibody-drug conjugates (ADCs). 

Ambrx’s synthetic biology technology platform is intended for designing and developing advanced ADCs. 

The integration of Ambrx’s ADC technology into J&J’s portfolio presents a unique opportunity to advance the development and commercialisation of targeted oncology therapies.

11 March

Novo expands Wegovy’s US label to reduce cardiovascular events

The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Wegovy (semaglutide) as a treatment to reduce the risk of major cardiovascular events such as cardiovascular death, heart attack, and stroke in adults with heart disease who are also either obese or overweight. 

Novo Nordisk has reported record profits generated from its obesity portfolio in the past few years. The company’s obesity drugs, Wegovy and Saxenda (liraglutide), generated DKr41.5bn ($6.1bn) in global sales last year, as per Novo’s 2023 annual report. Wegovy’s label expansion into cardiovascular disease is part of Novo’s strategy to establish itself in that sector.

The FDA approval was based on Phase III SELECT trial (NCT03574597) results. The study evaluated the effect of Wegovy in addition to the standard of care on the risk of cardiovascular events in 17,604 patients who were either obese or overweight. The study reported a 20% reduction in the relative risk of major cardiovascular events compared to placebo.