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Wegovy was registered with the Australian Register of Therapeutic Goods in 2022.
Update: Novo Nordisk said on Thursday (1/8/2024) that it launched its Wegovy weight-loss medicine in Australia, making the hugely popular drug available in 12 countries, including the United States, Denmark, Norway, Switzerland, United Arab Emirates, Japan, Britain, Germany, and Iceland.
The Danish pharmaceutical company has announced that Wegovy is now available in Australia in weekly injection containing 2.4 milligrams of semaglutide, the active ingredient in Wegovy.
Regulatory hurdles and approval process
Wegovy has faced significant regulatory hurdles in Australia, delaying its introduction to the market. The Pharmaceutical Benefits Advisory Committee (PBAC) has twice rejected applications to add Wegovy to the Pharmaceutical Benefits Scheme (PBS) as a treatment for severe obesity.
The PBAC cited concerns about cost-effectiveness at the proposed price and the need for a more reliable economic model from Novo Nordisk. Additionally, the committee requested better definition of eligible patients. While Wegovy has been approved as safe by Australia’s Therapeutic Goods Administration, these regulatory challenges have prevented its subsidization and widespread availability.
Novo Nordisk must now decide whether to launch Wegovy for private prescriptions in Australia, as the timing of its availability remains uncertain.
Comparing Wegovy and Ozempic
Wegovy and Ozempic are both injectable medications containing semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, but they have distinct FDA-approved uses and dosages.
Ozempic is primarily indicated for managing blood sugar in adults with type 2 diabetes and reducing cardiovascular risks, while Wegovy is specifically approved for chronic weight management in adults with obesity or overweight with related health conditions.
Wegovy offers a higher maximum dose of 2.4 mg weekly compared to Ozempic’s 2 mg, potentially leading to greater weight loss effectiveness. Both medications are administered via prefilled injection pens, with Wegovy pens being single-use and Ozempic pens containing multiple doses.
While they share similar side effect profiles, Wegovy may have a higher incidence of side effects due to its elevated dosage. The choice between Ozempic and Wegovy depends on individual health factors, treatment goals, and should be made in consultation with healthcare providers.
Impact of global supply shortages
Global supply chain disruptions have significantly impacted the availability of pharmaceuticals like Wegovy. The COVID-19 pandemic caused major disruptions to manufacturing and logistics, leading to shortages of raw materials and finished products across industries.
For pharmaceutical companies like Novo Nordisk, these supply chain issues have likely contributed to delays in launching new drugs in markets like Australia. Shortages of key components, production delays, and increased shipping costs have made it challenging to meet global demand for medications.
Additionally, the surge in demand for weight loss drugs like Wegovy in countries where it’s already available has further strained limited supplies.
These factors combined help explain why Wegovy’s Australian release has been pushed back, as Novo Nordisk works to secure reliable supply chains and meet existing demand before expanding to new markets.