Eli Lilly’s attempt to wrestle a leukemia market from companies including AbbVie, AstraZeneca, BeiGene and Johnson & Johnson has analysts purring, with the GlobalData team tipping the drugmaker to capture 60% of demand and deliver $3 billion in annual sales. The GlobalData report covers the use of BTK inhibitors in the treatment of chronic lymphocytic leukemia (CLL). Pharmacyclics, now part of AbbVie, and J&J created the market with Imbruvica but now face a sea of threats, with the Inflation Reduction Act, increased competition and the looming prospect of generics pointing to a downward trajectory. AstraZeneca’s Calquence began challenging Imbruvica for the CLL market in 2019 and BeiGene’s Brukinsa joined the party last year. But the GlobalData analysts expect Lilly to come from behind to become the dominant force in CLL in the coming years. Lilly won accelerated FDA approval for Jaypirca in CLL last month. While the drugmaker, which acquired Jaypirca in its $8 billion ...
A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. regulator said. Over the last several months, the agency has been looking into reports of suicidal thoughts or actions from users of the GLP-1 treatments gathered through its FDA Adverse Event Reporting System (FAERS), it said. “Because the information provided was often limited and because these events can be influenced by other potential factors, we determined that the information in these reports did not demonstrate a clear relationship with the use of (GLP-1s),” the FDA wrote. The agency said its reviews of clinical trials and observational studies found no association between the treatments and suicidal thoughts. Ten days ago, the FDA drew attention when it included the trendy therapies on a list of medicines it said it was monitoring for side ...
An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced by other factors, the FDA said. Consequently, the agency said it determined the reports did not demonstrate a clear relationship with GLP-1 drugs. This finding is preliminary. “However, because of the small number of suicidal thoughts or actions observed in both people ...
The FDA has found no clear relationship between GLP-1 drugs, such as Ozempic and Mounjaro, and reports of suicidal thoughts or actions. But the agency added that it can’t definitively rule out the risk, and its review is ongoing. By FRANK VINLUAN An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced ...
Don Tracy, Associate Editor Company cites potential safety risks for patients who ignore the intended indication of Mounjaro and Zepbound. In a letter to the public, Eli Lilly and Company warned against the use of its medicines for cosmetic weight loss. Citing the fact that neither Mounjaro or Zepbound are indicated for cosmetic purposes, the pharma company stressed that both are intended to treat serious diseases, with Mounjaro focusing on type 2 diabetes and Zepbound for obesity in specific BMI ranges of a BMI of 30 kg/m2 or greater or those who are overweight with a BMI ≥ 27 kg/m2 or greater. Additionally, caution is advised for patients with severe gastrointestinal conditions and the medications should only be prescribed by licensed healthcare professionals. “Patients should consult with their healthcare providers to determine whether Mounjaro or Zepbound is right for them,” the company stated in a press release. “Mounjaro and Zepbound ...
Eli Lilly has created a website to make it easier for patients to access medicines including its hot obesity drug Zepbound. The website, LillyDirect, combines telehealth and pharmacy services to provide access to Lilly’s portfolio of diabetes, migraine and obesity medicines. Companies including the weight loss program providers Noom and WeightWatchers have begun offering telehealth services to help people access Lilly’s Zepbound and Novo Nordisk’s Wegovy. Drugmakers have kept in their lane, though, developing and manufacturing medicines without getting into the business of connecting patients to physicians and delivering products to their homes. LillyDirect marks a shift in strategy, at least for Lilly. The website features sections to help people access healthcare, either remotely or in person, and details of how to send prescriptions to LillyDirect Pharmacy Solutions to get home deliveries of Lilly drugs. Lilly CEO David Ricks set out the thinking behind LillyDirect in a statement, framing the ...
Eli Lilly cancer drug Jaypirca is closing 2023 the same way it started—with an FDA approval. The latest regulatory nod adds two additional types of blood cancers to the list of indications for the therapy. Friday’s accelerated approval for Jaypirca covers the treatment of adults with either chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The once-daily oral drug is a small molecule designed to block Bruton’s tyrosine kinase, or BTK, a cancer-driving enzyme. While other drugs already do this, Lilly’s molecule has an edge. The FDA based its decision on the results of an open-label, single-arm Phase 1/2 study in blood cancers that included more than 100 patients with CLL or SLL previously treated with at least two prior lines of therapy. Participants had received a median of five prior lines of therapy; the FDA said 77% of these patients had discontinued a BTK inhibitor after their cancer ...
As AbbVie, Johnson & Johnson, AstraZeneca and BeiGene are battling it out in the same BTK inhibitor market, Eli Lilly is trailblazing a new path for the blood cancer drug class. On Friday, Dec.1, the FDA granted accelerated approval to Lilly’s Jaypirca for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy. Jaypirca, which is itself a BTK inhibitor, is now allowed following treatment with a BTK inhibitor and a BCL-2 inhibitor. The ability to help patients who have failed on a BTK inhibitor makes Jaypirca unique. The Lilly med is a non-covalent BTK inhibitor that binds to BTK by a mechanism different from existing covalent agents, namely AbbVie/J&J’s Imbruvica, AZ’s Calquence and BeiGene’s Brukinsa. “Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be ...
By Tristan Manalac Pictured: Eli Lilly’s Biotechnology Center in California Eli Lilly on Tuesday signed a license and collaboration agreement with Tokyo-based biotech PRISM BioLab to discover and develop small molecule inhibitors of protein-protein interactions. Under the terms of the deal, Lilly will make an upfront payment and pledges up to $660 million in preclinical, clinical and commercial development milestones. The Japanese biotech will also be eligible for royalties on future sales of any pharmaceutical product that emerges from the partnership. In return, Lilly will gain access to PRISM’s proprietary PepMetics platform, which synthesizes small molecule drug candidates that can behave like peptides, according to the biotech’s ...
In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.Novo has unveiled a new phase 3 trial pitting CagriSema, a fixed-dose combination of Wegovy and the investigational drug cagrilintide, against Lilly’s Zepbound in people with obesity, according to a clinicaltrials.gov entry. The study plans to enroll 800 patients, and those with diabetes are excluded. Its primary goal is to evaluate how well the two companies’ therapies could help people lose weight relative to each other after 72 weeks of treatment.In addition, the trial will measure the number of patients in each arm who’ve achieved at least 25% or 30% weight reduction at the end of treatment. Other secondary endpoints include changes in cholesterol levels, triglycerides, waist circumference, systolic blood pressure and serious side effects. The Novo trial comes about seven months after Lilly launched a head-to-head phase 3 study testing Zepbound—also known ...
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