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FDA approves novel Lilly drug for early breast cancer

Eli Lilly (NYSE:LLY) has announced that it has approved Verzenio (abemaciclib) for certain patients with HR+ HER2– high-risk early breast cancer.

The drug will become the first inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6) to hit the U.S. market.

“Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represent another important step forward for people who are in need of new treatment options,” said Jacob Van Naarden, president of Lilly Oncology, in a statement.

The twice-daily therapy Verzenio will be available in tablet forms at 50, 100, 150 and 200-mg dose levels.

Indianapolis–based Lilly noted that the FDA approval covered the use of the drug in tandem with endocrine therapy such as tamoxifen or an aromatase inhibitor.

Sp…

Lilly wins Erbitux label expansion for colorectal cancer indication

FDA has approved a new indication for Lilly‘s (NYSE:LLY) Erbitux (cetuximab injection) in combination with Pfizer’s Braftovi (encorafenib) to treat adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation confirmed with an FDA-approved test.

The indication covers previously-treated patients.

Erbitux is currently the only FDA-approved antibody that targets the epidermal growth factor receptor (EGFR). Merck (NYSE:MRK) was also involved in developing the drug.

The recent label expansion is based on data from Pfizer’s Phase 3 BEACON CRC study, which focused on patients with metastatic colorectal cancer with a BRAF V600E mutation.

The latest approval gives Erbitux a total of seven indications covering various colorectal and head-and-neck cancers.

“The BEACON study showed that the combination of ERBITUX and encorafenib significantly improved overall survival in patients with metastatic colorectal cancer with a BRAF V600E mu…

FDA grants expanded EUA to Lilly’s COVID-19 antibody cocktail

FDA has expanded the emergency use authorization for Lilly’s (NYSE:LLY) bamlanivimab and etesevimab combo to include post-exposure prophylaxis.

Earlier in the year, federal authorities had counseled against the use of the monoclonal antibody cocktail in several states given the rise of SARS-CoV-2 variants in the U.S., including Gamma (P.1) and Beta (B.1.351).

Meanwhile, demand for Regeneron’s REGEN-COV (casirivimab and imdevimab) antibody cocktail has grown, given its efficacy in fighting infection from a range of SARS-CoV-2 variants. The U.S. government recently agreed to purchase an additional 1.4 million doses of the COVID-19 antibody cocktail.

The revised EUA for bamlanivimab and etesevimab includes high-risk individuals 12 and older who are immunocompromised or have not been fully vaccinated, and have been in close proximity to someone infected with the novel coronavirus. The EUA also covers individuals with a high risk of exposure in an inst…

Lilly prices first sustainability bond

Eli Lilly and Company (NYSE: LLY) has announced its plan to issue €600 million in aggregate principal in the amount of 0.50% notes with 12-year maturity as part of its Environmental, Social and Governance (ESG) strategy.

In May, the company announced that it had updated its Environmental, Social and Governance (ESG) strategy, bolstering its investment in sustainability. The ESG strategy is based on five pillars outlined in its Sustainability Bond Framework. Those pillars including increasing access to medicines, improving lives and communities, empowering a diverse workforce, minimizing environmental impact, and operating ethically and responsibly.

“Lilly is taking another step forward in advancing our purpose of making life better for people around the world,” said Anat Ashkenazi, Lilly’s CFO, in a statement. “This sustainability bond is Lilly’s latest commitment to our ESG strategy, which is core to our mission.”

Ash…

Lilly’s donanemab could outclass aducanumab, but questions remain

FDA’s approval of Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) Alzheimer’s drug aducanumab has resulted in significant gains in those companies’ shares.

But Lilly’s (NYSE:LLY) donanemab could be “perhaps better and cheaper,” concluded a recent investor note from Truist.

Lilly recently announced that it plans to file for accelerated approval for donanemab in the second half of 2021 under the accelerated approval pathway. As a result, Truist has pushed its launch assumption up two years to 2023 and raised its sales projections for the amyloid-plaque clearing drug.

Assuming the amyloid hypothesis is valid, donanemab holds promise as a potential disease-modifying therapy. In a Phase 2 trial, the investigational drug appeared to promote roughly twice the plaque clearance at 18 months as aducanumab did. Earlier studies also suggested that donanemab cleared plaque aggressively. The potential cognitive benefits of that clearance, however, remain unclear.

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Lilly’s tirzepatide bests semaglutide in type 2 diabetes trial

Eli Lilly (NYSE:LLY) has announced that its investigational drug tirzepatide led to more substantial blood glucose and body weight improvements in a Phase 3 trial than semaglutide, a diabetes drug from Novo Nordisk (NYSE:NVO) that recently scored FDA approval for weight loss in early June.

Lilly’s SURPASS-2 results published in The New England Journal of Medicine show tirzepatide achieved superior A1C and body weight reductions compared to injectable semaglutide in adults with type 2 diabetes.

A JAMA opinion article recently posited that semaglutide could lead to a ‘new dawn’ for obesity treatment.

The Lilly trial randomly assigned patients to receive tirzepatide at doses of 5 mg, 10 mg, or 15 mg or a 1-mg dose of semaglutide.

Semaglutide is a glucagon-like peptide 1 receptor agonist. Conversely, tirzepatide is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist.

In the 40-week SURPASS-2 trial, i…

DoJ subpoenas Eli Lilly over bamlanivimab plant

In an SEC filing, Eli Lilly (NYSE:LLY.N) revealed that it had received a subpoena from the U.S. Department of Justice connected to a manufacturing site in New Jersey that produces bamlanivimab, one of two COVID-19 monoclonal antibodies it produces. The plant also produces the blockbuster Trulicity and cancer drugs.

Lilly did not state which types of documents the federal government had requested but noted that it is cooperating with the criminal probe. The U.S. government has not made any specific accusations against Lilly.

According to a Reuters report, Lilly employees had accused an executive of modifying federal documents to cover up quality control problems at the facility in Branchburg, New Jersey.

Get the full story form our sister site, Drug Discovery & Development.

HHS pauses use of Lilly’s COVID-19 antibody cocktail in several states

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

The U.S. Department of Health and Human Services (HHS) has recommended pausing the combination of Eli Lilly’s (NYSE:LLY) bamlanivimab/etesevimab in eight states, including Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon and Washington.

The agency’s reasoning for the decision is grounded in lab data that found the antibody cocktail is not effective against P.1 (Brazilian) or B.1.351 (South African) variants. Those variants comprise more than 10% of COVID-19 infections in the eight states mentioned above.

HHS still recommends Regeneron’s (NSDQ:REGN) REGEN-COV antibody cocktail in areas with significant spread of the P.1 and B.1.351 v…

FDA nixes EUA for Lilly’s bamlanivimab

On April 16, Lilly announced that it was requesting FDA to revoke the emergency use authorization (EUA) for the monoclonal antibody bamlanivimab (LY-CoV555) when used alone.

Hours after, the agency agreed to rescind the EUA on the grounds that bamlanivimab is potentially ineffective against some SARS-CoV-2 variants.

Bamlanivimab, however, won’t be disappearing as a COVID-19 treatment but will be paired with another monoclonal antibody known as etesevimab.

Get the full story from our sister site, Drug Discovery & Development.

GSK and Vir Biotechnology seek EUA for COVID-19 monoclonal antibody

GlaxoSmithKline and Vir Biotechnology have filed for emergency use authorization (EUA) for VIR-7831 (GSK4182136), a dual-action SARS-CoV-2 monoclonal antibody.

VIR-7831 is designed to stop SARS-CoV-2 viral entry into cells and accelerate the clearing of infected cells.

VIR-7831 would have a similar indication to other monoclonal antibodies that have won an EUA. It is intended for patients 12 or older who weigh at least 40 kg who have a high risk of hospitalization or death from COVID-19.

One notable example of a monoclonal antibody that has won such an EUA from the FDA is Lilly’s bamlanivimab, which is intended to be used soon after a positive COVID-19 test result is obtained but is contraindicated for patients who are hospitalized COVID-19 infections.

Compared with bamlanivimab, VIR-7831 may offer more resistance to SARS-CoV-2 variants based on preclinical data and a preprint study published in BioRxiv.

The U.S. government recently stopped…

U.S. government halts use of Lilly’s bamlanivimab monotherapy

The spread of SARS-CoV-2 variants has convinced the U.S. government to stop using Lilly’s COVID-19 monoclonal antibody therapy bamlanivimab when used alone.

The U.S. government will continue using bamlanivimab when paired with etesevimab, another monoclonal antibody.

The government pointed to the rising number of SARS-CoV-2 variants across the country as the reasoning behind the decision.

Lilly stresses that bamlanivimab and etesevimab together should offer stronger protection against SARS-CoV-2 variants than either when used alone.

Several variants can potentially reduce the neutralization by monoclonal antibody treatments, according to the CDC. Variants such as B.1.429 and B.1.427, which emerged in California, have significant resistance to neutralization from at least some monoclonal antibody therapies available in the U.S. The P.1 variant first spotted in Brazil, and the B.1.351 variant from South Africa have moderate resistance to such antibo…

Lilly’s bamlanivimab and etesevimab cut COVID-19 hospitalization and deaths in study

A recent Phase 3 trial found that bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) administered jointly led to an 87% reduction in hospitalization and deaths in high-risk patients recently diagnosed with COVID-19.

The randomized, double-blind, placebo-controlled trial administered 700 mg of bamlanivimab (LY-CoV555) and 1400 mg of etesevimab (LY-CoV016) to 511 patients in the treatment arm. FDA granted emergency use authorization to the dosing regimen, which is also supported by the European Medicines Agency’s Committee for Medicinal Products for Human Use. A total of 258 patients in the cohort of the BLAZE-1 study received a placebo.

There were no deaths in the treatment arm but four deaths in the placebo arm. All of the deaths were considered related to COVID-19.

The BLAZE-1 trial has been ongoing for several months, giving Lilly the ability some indication that its monoclonal antibodies are effective against a range of SARS-CoV-2 varia…