On 19 September 2024, Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a label expansion for Novo Nordisk’s Wegovy® (semaglutide 2.4mg) to reflect reduced symptoms and improved physical limitations and exercise function in people with obesity-related heart failure with preserved ejection fraction (HFpEF).

The positive opinion was based on positive results of two studies (STEP HFpEF and STEP HFpEF-DM) conducted in people with obesity-related HFpEF, with or without type 2 diabetes.

This follows the CHMP’s positive opinion in July 2024 for an update to the label for Wegovy® to reflect a risk reduction of major adverse cardiovascular events in adults with established cardiovascular disease and either overweight or obesity without diabetes.

On 10 September 2024, Swedish CDMO, Iconovo, announced that it has commenced developing an intranasally inhaled form of semaglutide for treatment of obesity.  The product will reportedly use an improved form of Iconovo’s existing intranasal inhaler “ICOone Nasal®”.

Iconovo plans to develop the semaglutide inhaler to the preclinical proof-of-concept stage and then seek licensing opportunities for its clinical development.  Iconovo says that it will not launch the product commercially until after expiry of Novo Nordisk’s semaglutide patents.

This follows reports of Sandoz’s planned 2026 generic semaglutide, Biocon/Biomm’s deal regarding generic Ozempic® (semaglutide) in Brazil, and the acceptance of Hangzhou Jiuyan Gene Engineering’s application for generic Ozempic® (semaglutide) in China.

On 6 September 2024, Novo Nordisk announced its presentation of 21 abstracts and other data at the 60^th Annual Meeting of the European Association for the Study of Diabetes (EASD) held from 9 to 13 September 2024.

The data to be presented include results from the COMBINE clinical program of IcoSema (insulin icodec/semaglutide combination) in patients with type 2 diabetes, and the FLOW trial evaluating semaglutide 1mg on kidney outcomes in people with type 2 diabetes and chronic kidney disease (CKD).

The presentations also encompass results from studies on Awiqli® (once weekly basal insulin icodec) in type 2 diabetes; kidney, cardiovascular and all-cause mortality outcomes of Ozempic® (semaglutide 1mg) with or without baseline MRA use in type 2 diabetes and CKD; and analyses from studies on Wegovy® (semaglutide 2.4mg) and Saxenda® (liraglutide).

In August 2024, a representative from Novo Nordisk announced that the company was planning to submit regulatory approval applications for IcoSema in jurisdictions outside the US.  Awiqli® (insulin icodec) has been approved in a number of jurisdictions including Europe (May 2024), Switzerland and Canada (June 2024), Japan (June 2024) and Australia (June 2024), and endorsed in China (June 2024).

On 5 September 2024, Novo Nordisk filed separate lawsuits in the US District Court for the District of Delaware against each of Sun Pharmaceutical and Mylan asserting infringement of US patent number 12,029,779 (granted 9 July 2024), which claims a method of reducing body weight by administering semaglutide.  The litigation reportedly follows the filing by Sun Pharmaceutical and Mylan of abbreviated new drug applications (ANDA) with the FDA for approval of generic versions of Novo Nordisk’s Wegovy® (semaglutide).

Novo Nordisk has previously taken legal action to prevent counterfeit versions of Ozempic® (semaglutide) and Wegovy® (semaglutide) from being sold in the US.  Litigation against two clinics settled in February 2024, with the companies involved being permanently banned from claiming their products are approved by the FDA and from using any Novo Nordisk logos or trade marks.  Additional US litigation regarding sale of compounded “semaglutide” was commenced by Novo Nordisk in May 2024.

On 3 September 2024, Bloomberg reported that Sandoz is planning a 2026 biosimilar semaglutide launch in Canada, reportedly after Novo Nordisk’s patent protection expires.  Sandoz launches in the US and Europe are not planned until the early 2030s.

This comes after Biocon’s announcement in April 2024 that it entered an exclusive licensing and supply agreement with Biomm for generic Ozempic® (semaglutide) in Brazil.  In the same month, Hangzhou Jiuyan Gene Engineering’s application for generic Ozempic® was accepted by regulators in China.

On 30 August 2024, an article published in the American Journal of Cardiology reported the results of an analysis of data from the SELECT (Semaglutide Effects on Cardiovascular Outcomes in Patients With Overweight or Obesity) trial in relation to the effects of semaglutide on mortality.  The analysis concluded that, compared to placebo, patients treated with semaglutide had lower rates of “all-cause death”, including both cardiovascular and non-cardiovascular death (primarily due to fewer infection-related deaths, especially from COVID-19).

The SELECT trial, sponsored by Novo Nordisk, involved over 17,000 patients with obesity or overweight and cardiovascular disease (without diabetes).  Findings from the SELECT trial, demonstrating a significant 20% reduction in major adverse cardiovascular events in adults with established cardiovascular disease, have provided support for Wegovy® (semaglutide) label expansions in the EU (July 2024) and US (March 2024).

A representative from Novo Nordisk has recently announced that the company is planning to submit regulatory approval applications for its insulin icodec and semaglutide combination (IcoSema) in jurisdictions outside the US.  The decision to file the applications reportedly follows completion of the Phase III COMBINE-1 study in Q2 2024 which demonstrated that the combination achieved its primary endpoint of superior blood sugar control after 52 weeks versus insulin icodec alone.

Novo Nordisk will not be seeking regulatory approval of IcoSema in the US at this stage following the issue of a Complete Response Letter (CRL) by the US FDA on 10 July 2024 regarding insulin icodec for diabetes mellitus.

Novo Nordisk’s insulin icodec was approved as Awiqli® in certain jurisdictions including Europe, Switzerland and Canada, Japan and Australia, and endorsed in China.

On 7 August 2024, Novo Nordisk released its financial report which showed a strong increase in profits in the first half of 2024.  Novo Nordisk’s total sales equalled DKK 133.4 billion in the first six months of 2024, an increase of 24% in DKK and 25% when measured according to constant exchange rates (CER).

Diabetes and Obesity care sales saw an increase of 27% (CER) to DKK 125 billion (US$18.3bn), primarily driven by GLP-1 diabetes sales growth of 32% (CER) and Obesity care, including products such as Ozempic, growing by 37% (CER).  Novo Nordisk reports that it continues to be the global market leader in the GLP-1 segment for diabetes care with 56% value market share.

Highlights for the first 6 months of 2024 are reported to include the approval of Awiqli® (insulin icodec) in the EU (March 2024), Japan and China (June 2024) and a label extension for Wegovy® (semaglutide) in the EU (July 2024).

The second half of 2024 is expected to see a further 22-28% (CER) growth in sales and operating profit is expected to grow by as much as 20-28% (CER).

On 2 August 2024, Australia’s Therapeutic Goods Administration announced that, according to Novo Nordisk, Wegovy® (semaglutide), specifically indicated for weight loss, will be available in Australia from early August 2024. While Wegovy® has been approved in Australia since 2022, it has never been sold in the country and is not available as a subsidised medicine under the Australian Pharmaceutical Benefits Scheme. This news comes in advance of an Australian Federal Government ban on pharmacy compounded copies of Novo Nordisk’s Ozempic® (semaglutide) and Eli Lilly’s Mounjaro® (tirzepatide), type 2 diabetes treatments widely used off-label for weight loss, which takes effect from 1 October 2024.

The Australian Pharmaceutical Benefits Assessment Committee (PBAC) November meeting promises to be a significant one for biopharmaceuticals based on the agenda published on 31 July 2024.

Two biosimilars will be considered: Sandoz’s Wyost® (denosumab) (biosimilar to Amgen’s Prolia®/Xgeva®) and Celltrion’s Steqeyma® (ustekinumab) (biosimilar to Janssen’s Stelara®).  Neither of these have yet received marketing approval.

Bayer is seeking listing on the Pharmaceutical Benefits Scheme (PBS) for an indication expansion for its Eylea® (aflibercept) for diabetic macular oedema and subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD).  MSD has applied for listing of a new strength of Ozempic® (semaglutide) (solution for injection 2 mg in 3 mL pre-filled pen) for type 2 diabetes.

Applications for PBS listing additions or amendments that the PBAC will consider at its November 2024 meeting include the following: