FDA approves novel pancreatic islet cell therapy for adults with type 1 diabetes by Jill Rollet for Healio.com/endocrinology, 29 June 2023.
The FDA approved an allogenic pancreatic islet cellular therapy for adults with type 1 diabetes who struggled to achieve their target HbA1c due to repeated episodes of severe hypoglycemia, according to an agency press release.
The novel cell therapy (Lantidra, CellTrans Inc.) is made from deceased donor pancreatic cells and is administered as a single infusion into the patient’s hepatic portal vein. According to the press release, the therapy’s mechanism of action is believed to be secretion of insulin by the infused islet beta cells, which may produce enough insulin in patients to allow them to no longer require insulin therapy. Additional infusions of islet cells may be required depending on response to the initial dose.
“Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Today’s approval, the first-ever cell therapy to treat patients with type 1 diabetes, provides individuals living with type 1 diabetes and recurrent severe hypoglycemia an additional treatment option to help achieve target blood glucose levels.”
Lilly to Acquire Sigilon Therapeutics in a press release from Sigilon Therapeutics, 29 June 2023.
Eli Lilly and Company and Sigilon Therapeutics, Inc. announced a definitive agreement for Lilly to acquire Sigilon, a biopharmaceutical company that seeks to develop functional cures for patients with a broad range of acute and chronic diseases. Since 2018, Lilly and Sigilon have worked together to develop encapsulated cell therapies, including SIG-002, for the treatment of type 1 diabetes. The goal of these therapies is to free patients from constant disease management by sensing blood glucose levels, restoring insulin production and releasing it over the long term.
“Despite significant advancement in treatment for people living with type 1 diabetes, many continue to live with a high disease burden every day,” said Ruth Gimeno, Ph.D., group vice president, diabetes, obesity and cardiometabolic research at Lilly. “By combining Sigilon’s talent and expertise in cell therapy with the knowledge and skills of Lilly’s research and development teams, we will enhance opportunities to create innovative islet cell therapy solutions to improve the care of people living with diabetes.”
Sernova says five diabetes patients have now been taken off insulin after ‘cell pouch’ therapy by LeiLei We for Endpts.com, 26 June 2023.
Five patients with type 1 diabetes have stopped taking insulin after getting Sernova’s cell transplant treatment, the Canadian biotech reported. It’s the latest data on a delivery approach for a potential one-time treatment for type 1 diabetes, though it comes with some significant limitations.
In a Phase I/II study being conducted at the University of Chicago, Sernova said that the first five patients on the trial have now been insulin-independent for at least 6 months. The first patient on the trial has been insulin-independent for just over three years. The data were presented at the American Diabetes Association annual meeting.
Sernova’s treatment takes islet cells, the pancreatic cells responsible for making insulin, from a donor and delivers them via what Sernova calls its “cell pouch” — a porous device that is implanted under the skin against the abdomen. The biotech is enrolling a second cohort of patients into its trial to test a larger version of its cell pouch, after patients in the first cohort required additional islet transplants to reach insulin-independence, and so far has dosed three patients.
LOTS on SGLT-2, GIP and more
Eli Lilly’s Triple Mechanism Sets New High Mark for Weight Loss Drugs by Frank Vinluan for MedCityNews.com, 27 June 2023.
Eli Lilly’s blockbuster drug in waiting, Mounjaro, hits two targets to treat type 2 diabetes and spark weight loss. The drug still awaits an FDA decision on its use for shedding weight, but Lilly is already following up with a potential successor and the pharmaceutical giant now has clinical data showing this molecule’s approach of addressing three targets leads to an even greater magnitude of weight loss.
The Lilly drug, retatrutide, led to an average 17.5% weight reduction from baseline (41.2 pounds or 18.7 kilograms) across four doses tested over 24 weeks in a Phase 2 study. Weight loss continued with longer treatment. At 48 weeks, the average weight reduction was 24.2% (57.8 pounds or 26.2 kg). These results were presented Monday during the annual meeting of the American Diabetes Association (ADA) and published simultaneously in The New England Journal of Medicine (NEJM).
The first generation of peptide drugs for diabetes and weight loss mimic a hormone called GLP-1, stimulating the body’s production of insulin to regulate blood sugar levels. Lilly markets one such drug, the once-weekly injectable medicine Trulicity. Ozempic, from rival Novo Nordisk is also a GLP-1 agonist.
Lilly designed Mounjaro to pair GLP-1 agonism with the activation of another hormone, GIP. Last year, the FDA approved Mounjaro for treating type 2 diabetes.
With retatrutide, Lilly adds one more mechanism, the activation of glucagon receptors. These receptors also play a role in regulating blood sugar. “We believe that combining glucagon receptor agonism with GIP and GLP-1 receptor agonism may be one of the reasons retatrutide showed this level of weight reduction,” Dan Skovronsky, Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories, said. The Phase 3 program will evaluate retatrutide in chronic weight management, obstructive sleep apnea, and knee osteoarthritis in those who are obese and overweight.
Survodutide induces up to 18.7% weight loss among adults with obesity in phase 2 trial by Michael Monostra for Healio.com/endocrinology, 30 June 2023.
Adults with overweight or obesity lost up to 18.7% of their body weight at 46 weeks with a glucagon/GLP-1 dual agonist. In data from a phase 2 trial presented at the American Diabetes Association Scientific Sessions, survodutide (Boehringer Ingelheim and Zealand Pharma) induced a greater weight loss than placebo at 46 weeks, and most participants receiving survodutide 3.6 mg or 4.8 mg lost more than 15% of their body weight.
“We are particularly impressed by the magnitude of weight loss benefit shown after 46 weeks of treatment with [survodutide],” Carel Le Roux, MD, PhD, professor of experimental pathology at the University College Dublin (UCD) School of Medicine and St. Vincent’s University Hospital said. “The efficacy seen suggests that this dual agonist mechanism of action, which adds glucagon receptor agonist activity, may have additive benefits to GLP-1 receptor agonists.”
Hold GLP-1 Agonists Before Elective Surgery by Kristen Monaco for MedPageToday.com, 30 June 2023.
Patients on GLP-1 receptor agonists should stop taking them prior to elective surgery due to concerns over increased risk for regurgitation and pulmonary aspiration of gastric contents while under general anesthesia, according to new guidance from the American Society of Anesthesiologists (ASA).
As detailed in the ASA’s Task Force on Preoperative Fasting statement this week, patients on one of the once-weekly injectable GLP-1 agents should not take their medication a week prior to surgery, and those on a once-daily agent should not take their medication the day of surgery, said Task Force Chair Girish P. Joshi, MBBS, MD, of the University of Texas Southwestern Medical Center in Dallas, and colleagues.
These recommendations apply to both adults and children on a GLP-1 receptor agonist. It also applies to all patients on an agent in this class, regardless of the indication (type 2 diabetes, obesity, etc.).
If patients with diabetes need to halt medication for longer than the dosing schedules, it’s advised that they consult an endocrinologist on the possible use of other antidiabetic therapies to avoid hyperglycemia.
Read more: Hold GLP-1 Agonists Before Elective Surgery
‘Alarming’ rise in diabetes expected globally by 2050 by Jennifer Rigby for Reuters.com, 22 June 2023.
Diabetes remains fastest-growing medtech market despite some risk from new drugs by Nick Paul Taylor for MedTechDive.com, 30 June 2023.
New diabetes medicines could apply “short-lived pressures” to medtech companies by affecting the use of insulin, according to analysts at Mizuho. The development of new medicines that control blood sugar and drive weight loss has started a debate about whether demand for insulin, insulin delivery devices and blood glucose management solutions will continue to rise in the coming years. After attending the American Diabetes Association’s annual Scientific Sessions, Mizuho analysts concluded that, while the new therapies pose “some risk” in the near term, the diabetes space will remain one of the fastest-growing medtech markets.
Based on the data and other considerations, the analysts expect the total addressable medtech market to expand, meaning diabetes is likely to remain one of the fast-growing markets in the industry in the years ahead.
Autonomous Artificial Intelligence Improved Adherence to Diabetic Eye Disease Testing by Connor Iapoce for HCPLive.com, 26 June 2023.
Autonomous artificial intelligence systems improved testing adherence for diabetic eye diseases (DED) across primary care clinics, according to new research. The results, presented at the 83rd Scientific Sessions of the American Diabetes Association (ADA 2023), suggested autonomous artificial intelligence decreased disparities in Black patients, who historically experience disadvantages in medical care.
“We looked at the real-world deployment at Johns Hopkins Medicine and found that autonomous artificial intelligence diabetic eye disease testing at primary care sites was associated with improved adherence, even after controlling for potential confounding factors,” presenting investigator T.Y. Alvin Liu, MD, assistant professor of ophthalmology, Wilmer Eye Institute, the Johns Hopkins School of Medicine, said at ADA 2023. “We also found that the deployment did improve access and equity, especially for patients of populations that were traditionally disadvantaged.”
Artificial intelligence aims to train a computer to act or think like a human; machine learning is a subtype that uses numerous data to train systems and deep learning acts as a subtype of machine learning. Recent advances in medical imaging analysis and language recognition are driven by deep learning. The US Food and Drug Administration (FDA) has approved the use of 3 autonomous artificial intelligence systems: the IDx-DR approved in 2018, EyeArt approved in 2020, and AEYE Health in 2022.
Data supports safety and accuracy of Senseonics 365-day CGM by Sean Whooley for DrugDeliveryBusiness.com, 26 June 2023.
Senseonics announced positive clinical data highlighting the effectiveness of its Eversense continuous glucose monitor (CGM). Senseonics presented two studies on its latest-generation Eversense E3 at the American Diabetes Association 83rd Scientific Session. The 180-day implantable CGM received FDA approval in February of last year. The sensor is fully implantable and requires just two sensor insertion and removal procedures per year. Senseonics’ latest data includes evidence supporting even longer wear time, plus more positive results for the existing platform.
“These data further bolster Eversense’s position as a leading CGM choice for people with diabetes,” said Dr. Francine Kaufman, Senseonics chief medical officer. “These recent studies are an important step forward as we continue to expand awareness of the system’s unique clinical benefits.
Eyenuk receives FDA approval for EyeArt v2.2.0 system released on MedicalDevice-Network.com, 23 June 2023.
Artificial intelligence digital health corporation Eyenuk has secured approval from the US Food and Drug Administration for its EyeArt v2.2.0 system. The approval expands the label of the EyeArt AI system, the company’s flagship product. It enables the use of Topcon NW400 retinal camera with the EyeArt AI system to automatically identify diabetic retinopathy. This system is already approved for use with Canon CR-2 AF and Canon CR-2 Plus AF cameras.
The EyeArt v2.2.0 system is claimed to be the first and only AI system approved by the US regulator for use with several retinal cameras by different manufacturers. The approval allows the company to add its Real-Time Image Quality Feedback solution and an upgraded image quality assessment module to the EyeArt system.
Eyenuk founder and CEO Kaushal Solanki said: “The EyeArt system can now be used with multiple camera models in the US, which significantly expands access for patients who can be screened in their primary care doctor’s office for preventable blindness due to diabetes.”
Medicare revises guidance on drug price negotiations amid lawsuits by Dulan Lokuwithana for SeekingAlpha.com, 30 June 2023.
The U.S. government revised its guidance on the Medicare drug price negotiation program as big pharma fights the newly introduced law in court. The program was introduced late last year under President Biden’s Inflation Reduction Act, allowing the Centers for Medicare & Medicaid Services (CMS) to negotiate drug prices for Medicare Part D beneficiaries for the first time in history.
The initial guidance released in March prompted drugmakers Merck and Bristol Myers as well as leading industry group Pharmaceutical Research and Manufacturers of America (PhRMA), to sue the government over its constitutionality. With the revised guidance, Medicare has introduced changes to the program’s confidentiality policy, which was a key argument cited in the lawsuits. As part of other changes, the CMS will allow drugmakers and the public to engage with the agency during the negotiation process.
WHO’s cancer research agency to say aspartame sweetener a possible carcinogen by Jennifer Rigby & Richa Naidu for Reuters.com, 29 June 2023.
Insulin treatment might boost cognition in people with mild cognitive impairment or Alzheimer’s disease by Eileen Bailey for MedicalNewsToday.com, 29 June 2023.
Intranasal insulin could produce some positive cognitive benefits, especially for people with Alzheimer’s disease and mild cognitive impairment, according to a report published in the journal PLOS ONE.
Researchers report that using intranasal insulin may improve cognitive functions in some people with dementia-related conditions. They said the insulin treatment appears to have the most benefits for people with Alzheimer’s disease and mild cognitive impairment. Other medical experts, however, said they felt the study was flawed and aren’t ready to recommend insulin as a treatment for these conditions.