en.Wedoany.com Reported - The European Medicines Agency has issued a positive review for the oral therapy Wegovy (semaglutide), used for weight management in obese patients. Novo Nordisk, the developer of this technology, is planning to roll out this oral formulation in several countries, including Spain. The company has disclosed to Redacción Médica the timeline and steps for bringing this drug into the public funding of the country's National Health System (SNS).
Semaglutide is a key active ingredient in the pharmaceutical industry, found in Novo Nordisk's drugs such as Ozempic, Rybelsus, and Wegovy. As a GLP-1 receptor agonist, it works by regulating blood sugar and suppressing appetite. Beyond the context surrounding the "Ozempic family" of drugs, medications with legal financing and distribution channels are beginning to establish a foothold in major countries.
Novo Nordisk noted that the oral formulation of Wegovy is currently only approved and available in the United States, which has been the first to experience the effects of this weight-loss drug converted from an injectable to a tablet. When asked about the timeline for Spain and other countries, company sources stated that they will continue to strive to bring innovations to more populations, adhering to local regulatory frameworks and other relevant factors.
Like all drugs that receive a positive assessment from the European Medicines Agency, Spain requires a national marketing authorization as well as a price and public funding resolution for Wegovy. Novo Nordisk reviewed the data supporting this weight-loss drug, noting that the U.S. approval was based on results from the Phase 3 clinical trial OASIS 4. The trial showed an average weight loss of approximately 14% in the overall analysis of all patients, and approximately 17% under the scenario assuming all patients continued treatment, always in combination with a low-calorie diet and increased physical activity.
Negotiations are ongoing regarding the inclusion of Wegovy in the public funding of Spain's National Health System (SNS). As disclosed by Redacción Médica several months ago, the current negotiations are focused on adding other formulations (i.e., non-oral formulations) to the product portfolio of the Spanish public health system, and discussions on the oral formulation have not yet begun. Novo Nordisk stated that dialogue with the Ministry of Health is actively progressing, with both parties committed to continuing collaboration to find viable solutions to ensure patient access to innovative treatments. The company will continue to work hand in hand with health authorities to explore pathways for the most needy patients to access treatment.
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