Lilly Archives - Medical Design Sourcing

Roche enters red-hot metabolic disease market with Carmot Therapeutics acquisition

Swiss pharma giant Roche had a limited presence in metabolic disease, but the firm has agreed to take over obesity drug developer Carmot Therapeutics for $2.7 billion, rivaling the dominance of next-gen obesity drug developers Novo Nordisk and Eli Lilly.

Carmot had been a rising star in biotech, attracting significant funding, including a $150 million Series E financing round in May 2023. The startup, having raised almost $385 million in total funding, had even flirted with an initial public offering (IPO) under the ticker CRMO., a rarity in the current climate.

CT-388 a valuable asset

Carmot’s lead asset is CT-388, a once-weekly injectable dual GLP-1/GIP receptor agonist for obesity, which has shown upbeat weight loss results in a phase 1b study. In the study, participants experienced more than 8% weight loss at 4 weeks. The drug candidate also appeared to be well-tolerated. In the study, The therapy demonstrated substantial weight loss compared to other…

Mirikizumab shows continued promise for ulcerative colitis after regulatory hiccup

Lilly has announced that its interleukin-23 blocker mirikizumab demonstrated promise in patients with moderately to severely active ulcerative colitis (UC) in the ongoing open-label LUCENT-3 extension study. The trial evaluated two-year efficacy and safety of the monoclonal antibody in patients who had previously undergone UC treatments, including biologics, that were ineffective, stopped working, or were intolerable.

In April, the company announced that it had received a complete response letter for mirikizumab for UC as a result of issues FDA identified related to the proposed manufacturing of the antibody. The agency noted no concerns about the clinical data package, safety, or label for the therapy.

After revealing the most recent LUCENT-3 data, Lilly plans on filing a marketing application for mirikizumab in Crohn’s disease to FDA. It intends to file paperwork with other regulatory agencies in 2024.

Mirikizumab efficacy in LUCENT-3

The LUCEN…

Lilly acquires Point Biopharma amid third FDA rejection in 2023

Eli Lilly and Company has recently received its third FDA rejection for the year 2023. The most recent came for lebrikizumab, the company’s investigational treatment for atopic dermatitis. FDA made the decision following an inspection of a third-party contract manufacturing organization. The agency had no complaints concerning the clinical data, safety, or labeling of lebrikizumab, but instead focused on quality control deficits.

Setbacks earlier in the year

Before the lebrikizumab setback, Lilly faced rejections for another antibody, mirikizumab, intended for ulcerative colitis. Donanemab, its Alzheimer’s disease was also affected. The former’s rejection also stemmed from manufacturing-related issues, while the latter faced concerns regarding the limited patient exposure during clinical trials.

Despite the hurdles, Lilly has fared extremely well on the stock market in 2023. Its share price is up more than 40% so far in 2023, trading most recently at $517…

Lilly publishes promising phase 2 trial data for retatrutide, a potential obesity therapy

Lilly has announced promising data from its NCT 04881760 phase 2 study of retatrutide, a potential obesity drug. The drug candidate, a single peptide with agonist activity at the glucose-dependent insulinotropic polypeptide (GIP), GLP-1 and glucagon receptors, was associated with significant weight loss, improved glycemic control and cardiovascular health.

At 24 weeks, retatrutide (1 mg, 4 mg, 8 mg or 12 mg) met the primary endpoint for efficacy in participants with obesity or overweight without diabetes. Participants had a mean weight reduction of up to 17.5% (41.2 lb) at 24 weeks. That figure increased to 24.2% at 48 weeks.

The double-blind, randomized, placebo-controlled study enrolled 338 adults with obesity or overweight and related health conditions to assess the drug’s efficacy, side effects, and safety. Data from that study were published in NEJM.

Lancet recently published data from the separate phase 2 NCT04867785 study on retatrutide, in…

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…

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…

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…

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…

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…

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…

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…

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…