Lilly gets FDA review for empagliflozin in chronic kidney disease

The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets as a potential therapy to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD).

Some 37 million people in the U.S. have CKD.

Lilly (NYSE:LLY) is developing the drug with Boehringer Ingelheim.

The supplemental New Drug Application includes data from the landmark EMPA-KIDNEY Phase 3 study, which found that empagliflozin led to a significant reduction in the risk of kidney disease progression or cardiovascular death in adults with CKD. In the study, the drug on top of  standard of care reduced the risk of kidney disease progression or cardiovascular death in adults by 28% compared with placebo.

EMPA-KIDNEY is an abbreviation of Empagliflozin in the Management of Patients with Advanced Chronic Kidney Disease.

The randomized, double-blind, placebo-controlled study (NCT03594110) enroll…

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FDA approves Olumiant for treating some hospitalized COVID-19 patients

[Olumiant image courtesy of Lilly]

The JAK inhibitor Olumiant (baricitinib) from Incyte (Nasdaq:INCY) and Lilly (NYSE: LLY) has scored FDA approval to treat hospitalized COVID-19 patients who need help breathing.

In particular, the new indication covers adult patients needing supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.

Olumiant first won FDA approval in 2018 for treating moderately-to-severely active rheumatoid arthritis.

Lilly began testing the drug in hospitalized COVID-19 patients in June 2020. It won emergency use authorization (EUA) for such patients in November of that same year when used with remdesivir.

FDA broadened the EUA in July 2021 to allow its use with or without remdesivir.

Olumiant is the first immunomodulatory therapy to score FDA approval for a COVID-19 indication.

The drug continues to be avail…

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Lilly’s lebrikizumab with topical corticosteroids improved atopic dermatitis in the study

Eli Lilly (NYSE:LLY) has announced promising results from a Phase 3 study of patients with moderate-to-severe atopic dermatitis (AD).

At 16 weeks, 70% of patients with moderate-to-severe atopic dermatitis (AD) taking both lebrikizumab and standard-of-care topical corticosteroids (TCS) achieved at least 75% improvement in overall disease severity (EASI-75*) in the ADhere trial.

The company made the announcement at the fourth annual Revolutionizing Atopic Dermatitis (RAD) Conference.

The combination of lebrikizumab, an experimental investigational interleukin (IL)-13 inhibitor, and topical corticosteroids also resulted in itch symptoms, sleep and quality of life compared with placebo and topical steroids.

“Today’s ADhere data, together with results from the ADvocate monotherapy studies, demonstrate the potential for lebrikizumab to reduce disease burden and provide relief for people with uncontrolled atopic dermatitis when used either al…

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Lilly stops Phase 3 Jardiance trial early thanks to clear positive efficacy data

The independent data monitoring committee overseeing the Phase 3 EMPA-KIDNEY trial investigating Lilly’s (NYSE:LLY) Jardiance (empagliflozin) concluded the therapy showed positive efficacy in a formal interim assessment.

Boehringer Ingelheim co-developed empagliflozin with Lilly.

The EMPA-KIDNEY trial focused on treating adults with chronic kidney disease (CKD).

The committee recommended that the Phase 3 study be stopped early, given clearly positive data.

Earlier, the Medical Research Council (MRC) Population Health Research Unit at the University of Oxford, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), concluded Jardiance met the prespecified positive efficacy criteria.

Jardiance was first FDA approved as a treatment for type 2 diabetes in 2014. An indication followed for reducing the risk of cardiovascular death in adults with type 2 diabetes in 2016.

Approvals followed in 2021 and 2022 for heart failure with r…

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J&J and Roche named to Clarivate’s Top 100 Global Innovators list 

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

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Lilly invests $700M in Boston Seaport site

15 Necco Street, Seaport Innovation District, Greater Boston. Image courtesy of Alexandria Real Estate Equities, Inc.

Eli Lilly and Company (NYSE:LLY) will spend roughly $700 million to build the Lilly Institute for Genetic Medicine in Boston’s Seaport neighborhood.

The facility will focus on RNA- and DNA-based therapeutics and draw resources from Lilly’s 2020 acquisition of Prevail Therapeutics for approximately $1 billion.

The new facility will be based in a 334,000 ft2 site in a 12-story building.

Lilly plans on occupying the site in 2024.

Before the acquisition, Prevail focused on developing disease-modifying AAV9-based gene therapies for neurodegenerative diseases.

“Establishing the Lilly Institute for Genetic Medicine will allow us to pair cutting-edge technologies with our deep biological expertise in several areas, including neuroscience and diabetes,R…

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FDA authorizes new antibody from Lilly that holds up to omicron

FDA has authorized bebtelovimab, a monoclonal antibody from Eli Lilly and Company (NYSE:LLY), for certain high-risk patients with COVID-19.

The emergency use authorization (EUA) for the antibody covers the treatment of mild-to-moderate COVID-19 in individuals at least 12 years of age who weigh at least 40 kg (about 88 pounds). The EUA is constrained to individuals who are not good candidates for existing approved or authorized alternative COVID-19 therapies.

The authorization covers a single 175-mg intravenous dose of bebtelovimab is 175 mg administered over at least 30 seconds.

Lilly began developing bebtelovimab early in 2021 and confirmed its potency against omicron in pseudovirus and authentic virus testing.

Dr. Daniel Skovronsky

The broadly neutralizing antibody “could be used to fight a highly mutated variant, should one emerge,” said Dr. Daniel Skovronsky, Lill…

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FDA authorizes COVID-19 antibody cocktail for younger children

The FDA will allow the use of Lilly’s (NYSE:LLY) bamlanivimab and etesevimab antibodies for younger pediatric patients, including newborns.

The revised expanded emergency use authorization (EUA) specifically includes children with mild-to-moderate COVID-19 who face a high risk of disease progression.

The EUA previously covered children at least 12 years of age who weigh at least 40 kilograms.

The FDA will now allow the use of the antibody cocktail as post-exposure prophylaxis (PEP) to prevent COVID-19 in all pediatric patients with a high risk of progressing to severe COVID-19.

Bamlanivimab and etesevimab image courtesy of Lilly.

The expanded authorization is not intended to provide an alternative to vaccination, said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “Vaccines remain our best tool in the fight against the virus, an…

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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.


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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…

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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…

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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.”


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