AstraZeneca's 'smoker's lung' therapy meets main goals of late-stage asthma trials
May 2 (Reuters) - AstraZeneca (AZN.L), opens new tab said on Friday its triple-combination inhaler Breztri Aerosphere met all main goals in two late-stage trials for uncontrolled asthma, showing clinically meaningful improvement in lung function.
The Anglo-Swedish drugmaker's therapy, already approved for the treatment of Chronic Obstructive Pulmonary Disease or "smoker's lung", was being compared with a dual-combination maintenance treatment in the trials.
here.
The results come as AstraZeneca targets $80 billion in revenue by 2030, after first-quarter sales this week missed expectations on weaker oncology drug performance.
Asthma is a common but chronic lung disease that makes breathing difficult due to inflammation and muscle tightening. It affected 262 million people and caused 455,000 deaths in 2019, according to the World Health Organization, opens new tab.
"The results from the ... trials are exciting and demonstrate the potential of budesonide/glycopyrronium/formoterol to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy," said Alberto Papi, primary investigator of the studies, referring to the compounds in Breztri Aerosphere.
AstraZeneca said on Friday it would share detailed results from the trials with authorities and seek to broaden approvals for Breztri, which brought in sales of $978 million last year and competes with GSK's Trelegy Ellipta.
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Scottish Sun
9 hours ago
- Scottish Sun
Are YOU eligible for free fat jabs on the NHS? As GPs start dishing out Mounjaro – all you need to know
Our round-up also reveals what you need to do if your GP denies you a fat jab prescription and advice if you're intending on buying them privately NATIONAL JAB SERVICE Are YOU eligible for free fat jabs on the NHS? As GPs start dishing out Mounjaro – all you need to know THEY are arguably the biggest medical breakthrough of recent times. And from Monday, so-called 'fat jabs' will be made available to many more Brits on the NHS. Advertisement 5 From Monday, GPs will begin prescribing the weight-loss jab Mounjaro in the first anti-obesity rollout of its kind Credit: Getty 5 Health chiefs hope the Mounjaro rollout will turn the tide on England's obesity crisis Credit: Getty In what marks the dawn of a new era, GPs will begin prescribing the weight-loss jab Mounjaro in the first anti-obesity rollout of its kind. More than three million people are thought to be eligible for tirzepatide - the active drug in Mounjaro - the strongest jab on the market. Health chiefs hope it will turn the tide on England's obesity crisis which has seen rates double since the 1990s. Advertisement Injections including Ozempic and Wegovy have previously only been available for type 2 diabetes or through specialist slimming clinics. Family doctors will now be encouraged to prescribe them in a bid to get more people on the meds. Experts hope widespread use will slash work sick days and boost the economy, while reducing rates of cancer, heart disease and dementia. But demand for the drugs is already huge and NHS clinics cannot dish them out fast enough. Here is everything you need to know as the rollout begins: Advertisement What is Mounjaro and what has it been used for so far? 5 Studies found Mounjaro caused 20 per cent weight loss over 18 months Credit: Reuters FOR anyone who has missed the frenzy, Mounjaro, aka tirzepatide, is the newest weight loss injection used on the NHS. It has been around since 2022 and triggers fullness hormones in the gut to prevent hunger and over-eating. This works the same as older jabs Wegovy and Ozempic, all known as GLP-1 agonists, but a recent trial showed it is more effective. A head-to-head study in the New England Journal of Medicine found Mounjaro caused 20 per cent weight loss over 18 months, while semaglutide – the active ingredient in Wegovy and Ozempic – led to 14 per cent. Advertisement All the jabs were originally invented to treat type 2 diabetes but trials found they could also cause major weight loss. Pharma firms have cashed in on the discovery and UK prescriptions have skyrocketed. NHS prescriptions of Mounjaro in England surged from just 3,300 in 2023 to 1.1million last year, and more than a million people are estimated to be buying it online. Weight Loss Jabs - Pros vs Cons Who will be eligible in the new rollout? THE new rollout starting on Monday will allow GPs to prescribe tirzepatide for weight loss, starting with those patients whose weight places them at greatest health risk. Top of the list will be those with a body mass index (BMI) of 40 or higher and four weight-related health conditions. Advertisement A BMI of 40 is roughly equal to weighing 16st (102kg) for an average height 5'3' woman, or 19st 6lbs (123kg) for an average 5'9' man. Weight-related conditions include high cholesterol, high blood pressure, prediabetes, type 2 diabetes, obstructive sleep apnoea and heart disease. Patients will likely be expected to have tried diet and exercise first before being offered a jab. Many are likely to miss out, as some 13.5million adults in England are obese but only 3.4million are estimated to be eligible in the rollout. How will the rollout be run and what is new? 5 Wes Streeting wants a more widespread use of the drugs but patients must also receive check-ups Credit: Getty Advertisement WHAT'S new is that the rollout will be the first run by NHS primary care, led by GP surgeries. In theory this should make life easier for patients – but GPs will not be able to meet the huge demand. NHS bosses have admitted it will take a staggering 12 years to treat everyone who is eligible. Just 220,000 extra people are likely to get Mounjaro by 2028. Private prescriptions, costing about £100-£150 per month, already vastly outnumber that and are rising. Advertisement Health Secretary Wes Streeting wants a faster rollout and more widespread use of the drugs but patients must also receive regular check-ups and lifestyle help. Officials are investigating whether they can dish them out through pharmacies or the NHS app to take a load off GPs. Professor Jason Halford, of the European Association for the Study of Obesity, said: 'These drugs have the potential to help millions. 'If the government and NHS are serious about prevention they need to reconsider their position on the speed of the rollout of these drugs.' Professor John Deanfield, a heart doctor at University College London, added: 'These drugs provide a real opportunity to delay many diseases of ageing all at the same time and potentially transform society. Advertisement 'I hope it won't take 10 years to do something that is so needed.' What if my GP says no? 5 If you are eligible but your GP denies you a prescription, you may be able to ask for a referral to specialist weight management services Credit: Getty MANY people are expected to miss out and some surgeries are already pouring cold water on patients' hopes. Fairhill Medical Practice in Kingston upon Thames said: 'Once we are able to prescribe weight loss injections they will be offered to those with the highest medical need only, which may mean that a lot of patients will be disappointed.' Millions who meet the prescription criteria will simply have to be denied the drugs because doctors are so busy. Advertisement On top of everything else England's 6,300 doctors' surgeries have to deal with, they do not have the capacity to offer the necessary long-term supervision for millions more people at once. Experts reckon private prescriptions will rocket even more as frustrated patients give up waiting. If you are eligible but your GP denies you a prescription, you may be able to ask for a referral to specialist weight management services. Known as tier 2 and tier 3 weight management services, they may prescribe the jabs after other weight loss attempts. 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Dose strength is partly based on size and pretending you are fatter than you are could mean you end up with a medication too strong for your body, raising the risk of serious side effects. The most common side effects from the injections include feeling sick, vomiting, diarrhoea or other gut troubles. If not treated properly people can suffer more serious impacts like dehydration, gallstones, pancreatitis or allergic reactions – and more than 100 deaths in the UK have so far been linked to the jabs. The General Pharmaceutical Council issued new rules in February to say that all pharmacies must verify a patient's height and weight, and conduct at least a video call – if not face-to-face appointment – before prescribing weight loss injections. Advertisement Dr Emily Pegg, associate vice president at Lilly, which makes Mounjaro, said: 'This is still a prescription-only medicine, should only be prescribed by a registered healthcare professional and needs to be dispensed by a registered pharmacy. 'It is not something that people should be able to buy by just going out and going on to a social media site and clicking a button and it gets delivered to them. 'That is not appropriate and is probably illegal. 'Patient safety is a high priority.' Everything you need to know about fat jabs Weight loss jabs are all the rage as studies and patient stories reveal they help people shed flab at almost unbelievable rates, as well as appearing to reduce the risk of serious diseases. Wegovy – a modified version of type 2 diabetes drug Ozempic – and Mounjaro are the leading weight loss injections used in the UK. Wegovy, real name semaglutide, has been used on the NHS for years while Mounjaro (tirzepatide) is a newer and more powerful addition to the market. Mounjaro accounts for most private prescriptions for weight loss and is set to join Wegovy as an NHS staple this year. How do they work? The jabs work by suppressing your appetite, making you eat less so your body burns fat for energy instead and you lose weight. They do this my mimicking a hormone called GLP-1, which signals to the brain when the stomach is full, so the drugs are officially called GLP-1 receptor agonists. They slow down digestion and increase insulin production, lowering blood sugar, which is why they were first developed to treat type 2 diabetes in which patients' sugar levels are too high. Can I get them? NHS prescriptions of weight loss drugs, mainly Wegovy and an older version called Saxenda (chemical name liraglutide), are controlled through specialist weight loss clinics. 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Dr Sarah Jarvis, GP and clinical consultant at said: 'One of the more uncommon side effects is severe acute pancreatitis, which is extremely painful and happens to one in 500 people.' Other uncommon side effects include altered taste, kidney problems, allergic reactions, gallbladder problems and hypoglycemia. Evidence has so far been inconclusive about whether the injections are damaging to patients' mental health. Figures obtained by The Sun show that, up to January 2025, 85 patient deaths in the UK were suspected to be linked to the medicines. Future of fat jabs WHILE the Mounjaro rollout is expected to kick off with a whimper and not a bang, it is hoped it will mark the beginning of a new era in weight loss medicine. Advertisement Brits have been getting gradually fatter for decades and no medication or government policy has managed to beat the bulge. The drugs appear super-effective, reasonably priced and relatively safe, and could help millions slim down after failed diets. 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Reuters
a day ago
- Reuters
Teens turn to weight loss drugs in fight against childhood obesity
Roughly 8 million American teens are living with obesity - that's one in five. For many, their weight has become a painful physical and emotional burden, isolating them from their peers as they struggle to slim down. But now there is another option: weight-loss drugs. Reuters reporters spent more than a year closely following four teenagers who joined a small but fast-growing cohort choosing to take this medication. This video contains content some people may find distressing. Lauren Roback reports.
Scottish Sun
a day ago
- Scottish Sun
Urgent warning over drug taken by millions – as AstraZeneca accused of ‘misreporting' safety data
Click to share on X/Twitter (Opens in new window) Click to share on Facebook (Opens in new window) MEDICS have raised concerns over a drug taken by millions to prevent heart attacks and strokes, claiming key safety data was "misreported" by its manufacturer AstraZeneca. Anti-clotting pill ticagrelor has been available on the NHS in 2011, after trials appeared to show it could prevent one in five deaths after a heart attack. Sign up for Scottish Sun newsletter Sign up 1 A BMJ investigation has raised concerns over clinical trials that spurred on the approval of ticagrelor, sold as Brilique But an investigation published in the BMJ cast doubt "over the integrity of the clinical trials that underpinned its approval". Ticagrelor is an antiplatelet medicine that prevents blood cells from sticking together and forming dangerous clots. The twice-daily pill is prescribed to patients with acute coronary syndrome who are at greater risk of blood clots due to a history of heart attack, angina or stroke - often in combination with a low dose of aspirin. In the UK, the drug is prescribed around 45,000 times per month on the NHS. Now, experts claim to have uncovered "evidence of serious misreporting" in two clinical trials that were pivotal to the drug's approval in the UK and US. These findings raise "doubts over the approval and decade long use of ticagrelor", sold as Brilique in the UK, the report authors wrote in the BMJ. In response, an AstraZeneca spokesperson told Sun Health: 'We are confident in the integrity of the trials and its evidence in support for Brilique.' Two AstraZeneca studies, known as ONSET/OFFSET and RESPOND, were published in the leading journal Circulation, reporting the drug's effects on platelet function. The ONSET/OFFSET trial involved 123 patients and found that ticagrelor was faster and better at preventing clots than a competitor drug. Similar results were published in RESPOND, which involved 98 patients. Early warning sign of heart attack you may notice in bed But the report authors claimed claimed 'primary endpoint' results in the two key trials - which were pivotal in determining the treatment's effectiveness - were inaccurately reported in Circulation. "We found evidence that the trials were inaccurately reported," they said. "In one instance, AstraZeneca's trial failed to show statistical significance, but was published in a leading cardiology journal as significant." It also said around a quarter of the readings from machines used in the trials were not included in the data sets, the US medicine's regulator, the Food and Drug Administration (FDA) used to approve the drug. In order for ticagrelor to get approved, clinical trials had to prove that it was a better drug than competitors in a phase 3 trial. After phase 3 and drug approval, the FDA and MHRA in the UK, continues monitoring it in phase 4 trials, to see if there are any additional problems with the drug. But the BMJ analysis of two phase 2 trial results found there were instances of patients whose blood "platelet aggregation dramatically increased". This is when blood cells stick together to form clumps, which can lead to blood clots - exactly what the drug aims to prevent. Key facts about ticagrelor Ticagrelor is an antiplatelet medicine that prevents platelets - a type of blood cell - from sticking together and forming a dangerous blood clot. Taking ticagrelor can help prevent blood clots if you have an increased risk of having them because you: Have had a heart attack Have unstable angina Have had a stroke or a transient ischaemic stroke (TIA, or mini-stroke) Ticagrelor is only available on prescription. You'll usually take ticagrelor twice a day and it's often prescribed together with low-dose aspirin at the start of treatment. The main side effects of ticagrelor are getting out of breath and bleeding more easily than normal. You may have nosebleeds, heavier periods, bleeding gums and bruising. According to medicines watchdog the National Institute for Health and Care Excellence (NICE), patients are advised to take the drug twice a day at 90mg for around a year after a heart attack. A lower dose of 60mg, may then be prescribed by doctors for up to a further three years. It may also be taken by those who have suffered a minor stroke or a transient ischaemic attack at 90mg alongside aspirin. Sources: NHS, NICE This is "an improbable effect for an anti-platelet drug" and "suggests an incorrect laboratory reading", the BMJ said. Assessing the readings from platelet machines used at the two trial sites, led by cardiologist Dr Paul Gurbel, investigators also found more than 60 of the 282 readings were not included in datasets submitted to the FDA. "The platelet activity levels not entered were significantly higher than those used in the Circulation papers and FDA datasets," they claimed. "It is unclear whose blood was sampled, and why those measurements did not contribute to data in either trial." The report authors conducted their investigation through interviews with trial investigators and platelet experts and access to the underlying trial data submitted to regulators. They also said that principal investigators involved in ticagrelor trials "were unreachable or declined to be interviewed". "The findings raise even deeper questions over the approval and decade long use of the drug," the authors claimed. Dr Victor Serebruany, an expert in cardiovascular pharmacology at Johns Hopkins University in Maryland, who has been critical of the drug for over a decade said: "It's been obvious for years that there is something wrong with the data. "That the FDA's leadership could look past all these problems- on top of the many problems their own reviewers identified and are now being discovered by The BMJ - is unconscionable. "We all need to know how and why that happened. "If doctors had known what happened in these trials, they would never have started using ticagrelor." But a spokesperson for the Sinai Center for Thrombosis Research and Drug Development, which Dr Gurbel leads, told MailOnline: "Any allegations of any research misconduct in the two studies are baseless and erroneous." Sun Health has also contacted Circulation for comment. The journal did not respond to the BMJ.
