The European Union’s drug regulator this week is going to discuss a significant proposal to broaden the use of Wegovy by Novo Nordisk (SPX: NOVOb.CO) (NYSE: NVO) (CPH: NOVO-B).
The regulator is considering the drug’s potential role in reducing the risk of strokes and heart attacks. This extends beyond its well-known weight-loss benefits. If approved, this expansion could significantly enhance Novo Nordisk’s position. It would advocate for Wegovy’s inclusion in public sector health systems across Europe.
Novo Nordisk’s Wegovy, along with the diabetes drug Ozempic, has witnessed a massive surge in demand. This has led to a remarkable doubling of the company’s share price over the past two years. However, the increase in demand has strained the company’s production capacity for the weekly injections. This has prompted a critical assessment of the challenges and opportunities in meeting this rising need.
While private purchases have been instrumental in increasing sales growth, analysts posit that broader coverage by public-sector insurers and health systems could provide the necessary impetus for sustained long-term momentum. However, despite this potential, certain European countries have historically approached health system coverage for weight loss drugs with caution. Additionally, some explicitly prohibit such payments by law.
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Insights from the SELECT Trial shed light
Insights from the SELECT drug trial are pivotal in evaluating Wegovy’s extended use. Published last year, the trial results indicated that the reduced cardiovascular risk from Wegovy became apparent shortly after obese participants started treatment. Previous studies had already showcased Wegovy’s efficacy in aiding obese patients to shed an average of 15% of their weight. Importantly, the SELECT trial separately showed a notable 20% reduction in the incidence of heart attacks, strokes, or death from heart disease.
In the past year, Novo Nordisk proactively sought label expansion for Wegovy from both the European Union and U.S. authorities. This is based on compelling trial data. The industry eagerly awaits the outcome of this pivotal step, as regulatory bodies can update labels with new data or reflect new indications post-initial approval.
In parallel, attention shifts to the horizon as U.S. obesity specialists contemplate the potential cardiovascular benefits of weight-loss drug, Zepbound, also known as Mounjaro, recently introduced by Eli Lilly ( NYSE: LLY) (CBEO CA: LLY-N). Analysts speculate on its comparative advantages, given its similar mode of action to Wegovy. This adds a layer of anticipation to the evolving landscape of weight-loss medications.
As the EMA conducts its monthly drug assessment meeting, the industry anticipates the regulator’s recommendations on Wegovy’s extended use, typically released on Fridays. The ultimate decision rests with the European Commission, which traditionally aligns its approvals with the EMA’s endorsements.
The outcome of this deliberation will shape the future of weight-loss medications in Europe and impact Novo Nordisk’s global pharmaceutical standing. The imminent decision has profound implications for public health policies, patient care, and advancements in combating obesity-related cardiovascular risks. The industry awaits this pivotal moment, expecting a verdict with far-reaching resonance.
zartasha@mugglehead.com
