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.
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.
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.
Novo Nordisk, the Danish drug manufacturer, has launched Wegovy, a weight-loss drug, in the UK market. This semaglutide injection will be available
through specialist NHS weight management services for those who meet the National Institute for Care and Excellence (NICE) criteria or privately through
registered healthcare professionals.
Novo Nordisk allocated a portion of the available supply of Wegovy for NHS services, while confirming the existing shortage of semaglutide and projecting
continued constraints in the foreseeable future. The drug can be obtained through the NHS and is additionally accessible for private purchase at pharmacies in the UK.
The pricing for a one-month supply varies, ranging from £73.25 to £175.80, depending on the dosage.
"We are committed to expanding treatment options for individuals with obesity and share the Government's goal of improving access to obesity care in areas of high
unmet medical need," the company said in a statement. "We are closely monitoring Wegovy demand and collaborating with regulators and providers to ensure access
to and continuity of treatment for people living with obesity."
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.
Weight loss drug Wegovy has transformed the obesity market and pharmaceutical companies with existing treatments are hoping the resulting demand will boost
demand for their older, less effective but cheaper, drugs.
A weekly injection of Wegovy, which was launched in the U.S. in June 2021, leads to an average weight loss of around 15%, alongside changes to diet and exercise.
Its impact has captured the attention of patients, investors and even celebrities.
But supply issues for Wegovy manufacturer Novo Nordisk means the Danish drugmaker has struggled to meet surging U.S. demand, delaying a launch in most of Europe.
Insurers and some national governments have also baulked at its cost, while a minority of patients do not respond to it.
Vivus and Currax Pharmaceuticals, U.S.-based developers whose treatments have been on the U.S. market for around a decade, hope to benefit from the attention and
supply shortage.
But scientists and investors say that lower efficacy plus side effects could continue to hold the treatments back.
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.
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A diabetes medicine, Mounjaro, has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat overweight patients.
The weight loss medication originally developed for Type 2 diabetes is now accessible to individuals aged 18 and over who are dealing with obesity and
weight-related health issues.
The active ingredient, tirzepatide, works by making the patient feel fuller and reducing food cravings.
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simultaneously.
Although it is not authorised to use on the NHS as yet but future approvals can be predicted.
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.
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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 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
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