Heart disease remains the number one killer globally, but the megablockbuster tirzepatide is proving it can do more than just help people lose weight – it’s now showing promise in fighting heart failure, too. In topline results from the phase 3 SUMMIT study, Lilly’s dual GIP/GLP-1 receptor agonist tirzepatide cut the risk of heart failure…
Tirzepatide cut sleep apnea index by up to 63% in phase 3 trials
Today, Lilly announced promising data for the SURMOUNT-OSA phase 3 clinical trials testing tirzepatide in adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. The company shared the data at the American Diabetes Association’s (ADA) 84th Scientific Sessions while publishing them in The New England Journal of Medicine (NEJM). The SURMOUNT-OSA phase 3 trial consists…
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…
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,…
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…
FDA approves Olumiant for treating some hospitalized COVID-19 patients
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…
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…
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…
J&J and Roche named to Clarivate’s Top 100 Global Innovators list
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…
Lilly invests $700M in Boston Seaport site
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…
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…
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…
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…
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…
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…
Reyvow indicated for treating migraines
Reyvow (lasmiditan) is an FDA-approved treatment from Lilly for the acute treatment of migraine with or without aura in adults. FDA has not approved it as a preventive treatment of migraine. In October, Lilly announced that the drug showed superior pain freedom after two hours of ingestion in two-thirds of migraine attacks in a Phase…
Olumiant offers hope to patients with rheumatoid arthritis
FDA has indicated Lilly‘s OLUMIANT (baricitinib) to treat adult patients with moderately to severely active rheumatoid arthritis. In particular, the agency has recommended the drug for patients with an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. In June, Lilly and its partner Incyte announced that the drug appeared to reduce…
Lilly’s donanemab may 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…
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…
Lilly’s push for accelerated FDA approval of Alzheimer’s drug donanemab
Eli Lilly (NYSE:LLY) has received breakthrough therapy designation from FDA for the investigational antibody donanemab for Alzheimer’s disease. The company plans to file a biologics license application for the drug under the accelerated approval pathway later this year. Like Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) recently approved aducanumab, donanemab is a monoclonal antibody clearing sticky amyloid plaques.…
HHS pauses use of Lilly’s COVID-19 antibody cocktail in several states
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…
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…
Lilly’s bamlanivimab and etesevimab cut COVID-19 hospitalization and deaths in study
A recent Phase 3 trial found that Lilly’s 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.…