Germany's Boehringer Ingelheim said on Thursday (Aug 17) it would conduct three late-stage studies for its obesity drug candidate after it showed up to
19 per cent weight loss after 46 weeks in a mid-stage trial.
The private company plans to start enrollments for the trial of the drug, survodutide, which it co-invented with Danish biotech company Zealand Pharma, before
the end of the year.
The trials will evaluate the drug's safety and efficacy, Boehringer said, and added that it would provide further details on the studies before initiation.
Boehringer and Zealand are among global drugmakers racing to grab a share of the potential $100 billion market for obesity treatments within a decade.
Survodutide works by mimicking a gut hormone called glucagon-like peptide-1 (GLP-1), which suppresses appetite, as well as imitating another gut hormone called
glucagon that helps break down fat.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication of semaglutide (Wegovy), authorising its use to reduce the risk
of serious heart problems and strokes in adults who are obese or overweight.
Semaglutide, a GLP-1 receptor agonist, was previously approved for use in the treatment of obesity and weight management, to be used alongside diet, physical
activity and behavioural support.
The latest approval establishes it as the first weight loss drug to be prescribed to prevent cardiovascular events, such as cardiovascular death, non-fatal heart
attack and non-fatal stroke, in people with established cardiovascular disease and a Body Mass Index (BMI) higher or equal to 27 kg/m2.
Novo Nordisk, the manufacturer of Wegovy, received this authorisation on 23 July following compelling evidence from a recent post-approval clinical study involving
over 17,600 participants.
The study demonstrated that Wegovy, administered at a dose of 2.4 mg once weekly via subcutaneous injection for up to five years, significantly lowers the incidence
of major adverse cardiovascular events (MACE) by 20 per cent compared to a placebo.
Amgen's experimental obesity drug demonstrated promising durability trends in an early trial, paving the way for a larger mid-stage study early next year,
company officials said ahead of a data presentation on Saturday (December 3).
The small Phase I trial found that patients maintained their weight loss for 70 days after receiving the highest tested dose of the injected drug, currently known as
AMG133.
Amgen shares have gained about 5% since the company said on Nov. 7 that 12 weeks of trial treatment at the highest monthly dose of AMG133 resulted in mean weight
loss of 14.5%.
At 150 days after the last dose, maintained weight loss had dropped to 11.2% below original weight at the start of the trial, according to findings detailed at a
meeting of World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease in Los Angeles.
Patients treated with AMG133 did have side effects including nausea and vomiting, but most cases were mild and resolved within a couple of days after the first dose,
Amgen said.
Wegovy maker Novo Nordisk said on Tuesday (Aug 8) a large study had shown the highly effective obesity treatment also had a clear cardiovascular benefit,
boosting the Danish company's hopes of moving beyond its image as a lifestyle drug.
The increasingly popular Wegovy has transformed the weight-loss market since its U.S. launch in June 2021, capturing the attention of patients, investors and
celebrities worldwide.
Novo's news lifted shares in Europe's second-most valuable listed company after LVMH by more than 17 per cent to record highs. They have now surged almost 165
per cent over the past two years.
The results of the late-stage trial may help persuade insurers in the U.S. and cost-conscious health authorities in Europe to cover the cost of Wegovy, which is
$1,300 a month in the United States, for a wider range of patients.
U.S. law classifies weight-loss treatments as lifestyle drugs and bars the Medicare health plan for older Americans from covering them and experts said the new
data could lead the U.S. government to reassess that.
The UK based Pharma giant Futura Medical Plc's lead product, Eroxon, a topical Stim-gel is now available on NHS prescription in England and Wales for the
treatment of Erectile Dysfunction (ED).
The Muti-Drug Resistant (MDR) approved alternative to PDE5i, Eroxon is available as an over-the counter off shelf at retailers like Boots and Superdrug; and is
available on NHS prescription in England and Wales as a CE-marked medical device.
Erectile dysfunction (ED), also known as impotence, is the inability to get and maintain an erection, typically concerning men over the age of 40 due to both,
psychological and physical causes such as anxiety, depression, diabetes, and obesity.
According to UK Conformity Assessed (UKCA), the approval of the medication is based on evidence from 2 Phase three clinical studies, which showed that
60 per cent of patients taking Eroxon achieved Minimal Clinically Important Differences (MCID) at 12 weeks.
The National Institute for Health and Care Excellence (NICE)'s independent committee has called for more research to ensure liposuction for treatment of chronic lipoedema is safe and effective enough for use on the NHS.
Lipoedema is more prevalent in women and very rarely affects men. It is characterised by an abnormal, usually symmetrical, accumulation of fat in the legs, hips, buttocks, and occasionally arms. It is a separate condition to obesity and lymphoedema.
The cause of lipoedema is unknown, but hormonal changes, weight gain and genetics are thought to be involved. The size and shape of legs, and the resultant mobility issues and pain, can have a profoundly negative effect on quality of life, and physical and mental health.
The interventional procedures advisory committee reviewed evidence from several sources, including eight before-and-after studies. The committee was informed that
several different liposuction techniques are used and that they may have different safety and efficacy profiles.