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Sales of diabetes drug Mounjaro totalled $3.1bn in Q2, compared to $979.7m in the same period last year. Credit: Mohammed_Al_Ali / Shutterstock

Eli Lilly has raised its revenue guidance for 2024, as weight-loss drug Zepbound (tirzepatide) propelled the drugmaker’s financial performance in the second quarter.

Shares in the company opened 11.8% higher when the market opened following the Q2 earnings release on 8 August. Though shares dipped during the day, prices recovered when the market opened on 9 August. Eli Lilly has a market cap of $761.1bn, currently making it the most valuable pharmaceutical company in the world.

Eli Lilly raised its full-year sales forecast by $3bn to the range of $45.4bn to $46.6bn. The company cited strong performance from Zepbound, as well as its type 2 diabetes treatment counterpart Mounjaro, which has the same active ingredient of tirzepatide.

Zepbound, launched in the US in November 2023, saw revenues of $1.24bn for Q2. For comparison, its revenue in Q1 was $517m, meaning the drug has already achieved blockbuster status for the calendar year, bringing in sales so far of over $1.7bn. 

The US Food and Drug Administration (FDA) has approved Sandoz’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD).

Available as a 2mg vial kit and pre-filled syringe, the biosimilar– which references Regeneron and Bayer’s Eylea (aflibercept) – is indicated to improve and maintain visual acuity in patients with the eye disease.

Enzeevu joins Biocon Biologics’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) in the list of FDA-approved biosimilars to Eylea. Yesafili and Opuviz were both greenlit by the agency as the first biosimilars in May this year. They were both designated as interchangeable products.

The FDA has provisionally said Enzeevu would be interchangeable with Eylea as “it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products”, as per a 12 August press release

Sangamo Therapeutics has signed a global licence agreement with Roche Group member Genentech for the development of genomic medicines to treat neurodegenerative diseases.

The collaboration focuses on intravenously administered treatments targeting the tau gene, associated with Alzheimer’s disease and other tauopathies.

Sangamo has granted Genentech an exclusive licence for its zinc finger repressors for the tau gene and the neurology target.

Sangamo’s neurotropic adeno-associated virus (AAV) capsid, STAC-BBB, will be exclusively licensed to Genentech for these targets.

Sangamo is tasked with concluding a technology transfer and certain preclinical works, while Genentech will handle the complete clinical development, regulatory works, manufacture and commercialisation of the assets globally. 

Bayer is looking to expand the use of Kerendia (finerenone) beyond type 2 diabetes (T2D), as the therapy showed efficacy in reducing the risk of cardiovascular outcomes in patients with heart failure.

Kerendia’s Phase III FINEARTS-HF trial (NCT04435626) met its composite primary endpoint by reducing the risk of cardiovascular death and heart failure. Bayer plans to submit the data from the study for regulatory approval with the US Food and Drug Administration (FDA).

Kerendia is non-steroidal, selective mineralocorticoid receptor antagonist. In 2021, the FDA approved it for reducing the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalisation for heart failure in adult patients with chronic kidney disease associated with T2D. Per Bayer’s financials, Kerendia generated €270m ($295.5m) in sales last year. GlobalData expects the therapy to earn more than $2.1bn in sales by 2030. 

Three years after an arimoclomol approval application was rejected, a US Food and Drug Administration (FDA) Genetic Metabolic Diseases Advisory Committee (GeMDAC) has voted in favour of approving Zevra Therapeutics’ drug for an ultra-rare neurodegenerative disease. 

The panel’s recommendation made on 2 August, in which 11 out of 16 members voted yes to approval as a treatment of Niemann-Pick disease type C, will now be considered by the FDA. Whilst the agency is not mandated to follow the advisory committee’s decision, it historically does so. 

Arimoclomol’s new drug application (NDA) has a Prescription Drug User Fee Act (PDUFA) action date of 21 September 2024, according to a 2 August press release by the US company. 

If the FDA agrees with the panel and greenlights the drug, arimoclomol will be the first therapy approved for Niemann-Pick disease type C in the US.