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Pharmaceutical companies AbbVie and Eli Lilly have withdrawn from Britain's voluntary medicines pricing agreement, an industry body said on Monday. Companies are increasingly arguing that it is no longer possible to justify the UK's "voluntary scheme" to global boardrooms and investors as repayment rates in 2023 have surged to 26.5 per cent of revenue, the Association of the British Pharmaceutical Industry (ABPI) said in a statement. "The current scheme has harmed innovation, with costs spiralling out of control, and the UK falling behind other major countries to be left as a global outlier," said Laura Steele, president and general manager for Eli Lilly's Northern Europe division. ABPI said it was seeking early talks with the government to set out a new future settlement. In December, the industry body had said the government raised the amount manufacturers of branded medicines within the voluntary scheme will be required to return to almost £3.3 billion in sales revenue from an earlier amount of £1.8 billion.

An experimental Alzheimer's drug developed by Eli Lilly and Co slowed cognitive decline by 35% in a late-stage trial, the company said on Wednesday, providing what experts say is the strongest evidence yet that removing sticky amyloid plaques from the brain benefits patients with the fatal disease. Lilly's drug, donanemab, met all goals of the trial, the company said. It slowed progression of Alzheimer's by 35% compared to a placebo in 1,182 people with early-stage disease whose brains had deposits of two key Alzheimer's proteins, beta amyloid as well as intermediate levels of tau, a protein linked with disease progression and brain cell death. The study also evaluated the drug in 552 patients with high levels of tau and found that when both groups were combined, donanemab slowed progression by 29% based on a commonly used scale of dementia progression known as the Clinical Dementia Rating Scale (CDR-SB). Using that scale, experts said Lilly's findings were roughly on par with Eisai Co Ltd and Biogen Inc's lecanemab, sold under the brand name Leqembi, which reduced cognitive decline by 27% in patients with early Alzheimer's in a study published last year. The results drove Lilly's shares to a record high, up more than 6% at $429.85. Dr. Ronald Petersen, an Alzheimer's researcher at Mayo Clinic, said Lilly's trial is the third to show removing amyloid from the brain slows progression of the disease, which could put to rest some lingering doubts about the benefits of drugs in the class and the amyloid-lowering theory. "It's modest, but I think it's real," he said of the benefit, "and I think it's clinically meaningful." Dr. Erik Musiek, a Washington University neurologist at Barnes-Jewish Hospital, said the efficacy looks as good or better than lecanemab.

Eli Lilly's weight-loss medicine Mounjaro, also known as tirzepatide, will be available in the UK within weeks as a four-dose pre-filled injection pen. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the drug to treat adults with type 2 diabetes and for weight management in obese patients. Branded as Mounjaro KwikPen, the injection is to be used together with a reduced-calorie diet and increased physical activity, the regulator said. "The public health importance of safe and effective treatments to help manage diabetes and obesity, which can have a significant impact on people's health, is clear. "This approval enables access to the approved Mounjaro pen in a more convenient presentation of a month's treatment, of one dose per week," said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.

PBR Staff Writer Published 22 April 2014 Swiss pharmaceutical firm Novartis has entered into a definitive agreement to acquire the oncology unit of Britain's GlaxoSmithKline (GSK) for about $14.5bn and up to $1.5bn contingent on a development milestone. As part of the deal, Novartis would have opt-in rights to GSK's current and future oncology R&D pipeline.

Apple has joined forces with Eli Lilly and Evidation Health on a new feasibility study to detect evidence of brain decline with data from personal digital devices. The research has revealed that these devices may help in the identification of mild cognitive impairment (MCI) and Alzheimer's disease dementia.

The Association of the British Pharmaceutical Industry (ABPI) on Thursday (February 2) called for the government to scrap its plans to raise the repayment rates for drugmakers, to avoid possible setbacks in the sector. Drugmakers that are part of the government's voluntary scheme agreement, which makes branded medicines affordable for people, are required to pay a part of their drug revenue to the government. The Department of Health and Social Care plans to raise the revenue clawback rate to 27.5 per cent from 24.5 per cent. The country's ongoing attempt to raise rates is likely to send the "worst possible signal" to global investors and boardrooms, said the ABPI. "Hiking these clawbacks to such uncompetitive levels risks undermining the UK's offer to global life sciences companies," Richard Torbett, chief executive of the ABPI, said in a statement. Pharmaceuticals giants AbbVie and Eli Lilly withdrew from the UK's voluntary drug pricing agreement in January after the repayment rates surged to 26.5 per cent.

Diabetes drugs that also promote weight loss such as Novo Nordisk's Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer's disease. Diabetes regimens, from Ozempic to old mainstays like insulin and metformin, appear to address several different aspects of the metabolic system implicated in Alzheimer's disease, including a protein called amyloid and inflammation, researchers say. The hope is that improving glucose utilisation and tamping down inflammation in the entire body - including the brain - could slow progression of debilitating diseases like Alzheimer's and Parkinson's. Several scientists interviewed by Reuters news agency pointed to mounting research supporting testing diabetes drugs against neurodegenerative diseases. Results are years away and success uncertain. But interest has been buoyed by recent positive data on Alzheimer's drugs developed by Eisai with partner Biogen and by Eli Lilly demonstrating that removing sticky amyloid plaques accumulated in the brain can slow cognition decline caused by the fatal mind-wasting disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs.

Denmark's Zealand Pharma and Boehringer Ingelheim said their experimental obesity treatment achieved up to 14.9% weight loss in a mid-stage trial, lining up a potential contestant in the booming obesity drug market. In a statement on Wednesday (May 10), the partners said that the Phase II dose-finding trial met its primary endpoint of weight loss after 46 weeks. Paola Casarosa, head of therapeutic areas at Germany's Boehringer Ingelheim told Reuters the partners are in discussion with regulators about the design of a planned follow-up trial in the third and last phase of testing. The enormous demand for weight-loss treatments such as Novo Nordisk's Wegovy, or potentially Eli Lilly's Mounjaro, could support as many as 10 competing products with annual sales reaching up to $100 billion within a decade, mostly in the United States, industry executives and analysts said. Lilly said about a year ago that Mounjaro was shown to reduce up to 22.5% in weight after 72 weeks of treatment in a much larger late-stage trial.

National Institute of Health and Care Excellence (NICE) has not recommended 'Tirzepatide', also known as Mounjaro, developed by Eli Lilly, in its draft guidance issued on Tuesday (27 June) for treating type 2 diabetes in adults alongside diet and exercise. The independent NICE committee recognised the importance of new treatment options given that fewer than two-thirds of the adults with type 2 diabetes have adequate glucose control when using current treatment options. Evidence submitted to the committee from clinical trials showed the use of tirzepatide at any dose resulted in better glucose control and lower weight compared with semaglutide or insulin therapy. The weight reduction was more pronounced with higher doses of tirzepatide, while the effect on glucose levels seemed less dose-dependent. Similar effects were observed against all GLP-1 receptor agonists in company's network meta-analysis, but this was uncertain. The committee have asked the company to provide more data to address the uncertainties in the clinical evidence, when compared to all relevant alternative treatments.

New data on weight loss drugs that could compete with Novo Nordisk's Wegovy are raising expectations there will soon be more options, and possibly lower prices, in an estimated $100 billion marketplace, doctors and pharmaceutical executives say. Drugmakers are ratcheting up their research and aiming for new formulations that can be taken as pills, options to deliver higher weight loss or drugs that reduce fat while maintaining muscle. "It has really been an explosion of innovation," said Dr. Robert Gabbay, chief science officer at the American Diabetes Association (ADA), which receives funding from both Novo and Eli Lilly and Co and just concluded its annual meeting in San Diego, California. "If there are multiple (treatments) in the market, that will lead to some level of competition and greater access."

The National Institute for Health and Care Excellence (NICE) has recommended abemaciclib also called Verzenios, made by Eli Lilly, for people with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence who have had surgery to remove their tumour. The clinical trial result showed that people having abemaciclib with hormone therapy had a more than 30 per cent better chance of their cancer not coming back following surgery compared with people having hormone therapy alone. Helen Knight, interim director of medicines evaluation at NICE, said: "Today's positive draft recommendation, which comes less than a month after abemaciclib received its licence, is fantastic news. The fact that we have been able to produce draft recommendations so quickly is testament to the success of our ambition to support patient access to clinically and cost effective treatments as early as possible. "Until now there have been no targeted treatments for people with this type of breast cancer. Abemaciclib with hormone therapy represents a significant improvement in how it is treated because being able to have a targeted treatment earlier after surgery will increase the chance of curing the disease and reduce the likelihood of developing incurable advanced disease."

A 58-year-old nurse from North Lanarkshire, Scotland, has reportedly died after taking the weight-loss drug tirzepatide, which was recently approved for use on the NHS. Susan McGowan died from multiple organ failure, septic shock and pancreatitis, with the use of the Eli Lilly drug listed as a contributing factor on her death certificate, according to the BBC. She had taken two low-dose injections of tirzepatide, known by the brand name Mounjaro, over a two-week period before her death on 4 September. Her death is thought to be the first in the U.K. officially linked to the drug. McGowan, who had worked for over 30 years as a nurse at University Hospital Monklands in Airdrie, purchased a prescription for the drug through a registered online pharmacy. A few days after her second injection, McGowen began experiencing severe stomach pains and sickness. She went to A&E at Monklands - where her colleagues tried to save her life. Within days, her kidneys failed, and she fell into a coma as her other organs began to fail.

Professor Kamila Hawthorne, chair of the Royal College of GPs, has cautioned that while weight loss drugs hold significant potential to enhance many patients' lives, they are not without risks. She also expressed concern that expanding the roll out of tirzepatide at the scale proposed by the National Institute for Health and Care Excellence (NICE) would have "significant practical and resource implications for the NHS and primary care." The final draft guidance from NICE, published on 5 December, suggests that around 220,000 people living with obesity will be offered the weekly injection, along with a reduced-calorie diet and increased physical activity, over the next three years. Marketed under the brand name Mounjaro by Eli Lilly, tirzepatide is recommended for people with a body mass index (BMI) of more than 35 and at least one weight-related illness. Accepting the request from NHS England to roll out the medication over 12 years, the NICE guidance proposes to prioritise those with the highest clinical need.

A new class of weight loss drugs developed by Novo Nordisk and Eli Lilly "opens the possibility of an end to the obesity pandemic" alongside other interventions, the World Health Organisation (WHO) said this week. But the global health agency said it has concerns that unless health systems prepare properly, the drugs could distort the response to the global obesity crisis, risking leaving people behind and overshadowing other steps to improve health. The new drugs "have the potential to be transformative", according to the WHO's chief scientist, Jeremy Farrar, its director of nutrition, Francesco Branca, and his senior adviser, Francesca Celleti, in an opinion piece in the Journal of the American Medical Association (JAMA). The article is the agency's clearest comment yet on the potential of the new drugs, known as GLP-1 receptor agonists. But "medication in isolation will not be enough to address the obesity crisis," they added, calling instead for the innovation to push clinicians, governments, the pharmaceutical industry and the public towards considering the condition a chronic disease that needs further study into how best to prevent and treat it.

Britons paying privately for obesity drugs are increasingly choosing Eli Lilly's Mounjaro over Novo Nordisk's Wegovy, online pharmacies say, in a sign the US drugmaker is gaining ground on its European rival. Mounjaro is appealing to people because of its greater efficacy, six online pharmacies and two patients told Reuters, showing Novo's first-mover advantage is being challenged in the UK even though some pharmacies sell starter doses for the weekly injection for up to 40 per cent more than Wegovy. "Mounjaro is now vastly outstripping Wegovy," said Chemist4U CEO James O'Loan, who said for the past three to four months, Mounjaro has won about 70 per cent of its sales. Chemist4U and another online seller, Simple Online Pharmacy, estimate that as many as 500,000 people in the UK currently take either Mounjaro or Wegovy via prescriptions from private online pharmacies. Mounjaro, unlike Wegovy, is not available through the National Health Service (NHS) though it likely will be next year. Wegovy is only available through the NHS at specialist obesity clinics and in limited circumstances. There is no public data on prescription numbers but the government said last year it had capacity to treat about 35,000 patients.

The MHRA on Wednesday granted a license for Eli Lilly's new Alzheimer's treatment, donanemab, for use in adults with mild cognitive impairment or mild dementia due to Alzheimer's disease. However, the drug will not be available on the NHS, as the National Institute for Health and Care Excellence (NICE) concluded that it "does not currently demonstrate value for the NHS." The health spending watchdog explained that the costs of providing donanemab, including regular infusions and intensive monitoring for serious side effects, outweigh the relatively small benefits it offers to patients, and so it "cannot currently be considered good value for the taxpayer." Helen Knight, director of medicines evaluation at NICE, said: "For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers' money. Donanemab (also called Kisunla) is a monoclonal antibody drug given by infusion (through a drip in the arm). It targets and reduces beta-amyloid proteins, whose abnormal buildup is associated with Alzheimer's disease. Clinical trial evidence suggests that the monthly injection can slow Alzheimer's disease progression by 4 to 7 months.