Novo Nordisk’s Wegovy is a Heart-Risk-Reducing Product.

(VOR News) – The European Union’s medical regulator has granted approval to Wegovy, a blockbuster weight loss treatment manufactured by Novo Nordisk, in order to expand its application to include the reduction of major heart events in overweight or obese adults.

In order to expand the scope of the medication’s applicability, this authorisation was granted. The purpose of obtaining this approval was to broaden the medicine’s application.

The Danish pharmaceutical company announced on Thursday that the European Medical Agency has formulated a “positive opinion” regarding the label’s expansion.

The agency made this determination after conducting a comprehensive examination of the results of a SELECT study that was subjected to rigorous monitoring. Other applications of the substance are facilitated by this conclusion.

The SELECT experiment, which was financed by Novo Nordisk and published in August 2023.

Wegovy and Ozempic contain semaglutide as the active ingredient.

Reduced the risk of major cardiovascular events by twenty percent when compared to a placebo. The researchers arrived at this conclusion. This realisation was the outcome of the researchers’ investigation.

The notion that the European Medicines Agency label for Wegovy should be amended is a significant step forward for patients who are coping with cardiovascular disease and obesity, according to Martin Holst Lange, executive vice president and director of development at Novo Nordisk.

The company’s statement, which was disclosed, indicated that the recommendation to update the label is a substantial advancement.

It is evident that Wegovy has the potential to save lives by reducing the likelihood of significant adverse cardiovascular events, as evidenced by the findings of the SELECT research. An additional benefit of participating in this exercise is that it helps individuals effectively manage their weight, which is a benefit in and of itself.

The company also stated that the label update incorporates data from the SELECT trial, which showed a 15% reduction in the risk of death from cardiovascular causes and a 19% reduction in the risk of death from any cause when compared to situations in which a placebo was used in conjunction with the product.

The SELECT trial was conducted in the United States, according to the company. Furthermore, the organisation disclosed that the SELECT investigation was conducted in the United States of America.

It is anticipated that the label amendment will be implemented within the next month, as per the statement issued by Novo Nordisk.

Wegovy has also been approved for use in the United States.

Similarly, the UK medical regulator has taken similar actions. The United Kingdom on Tuesday granted its clearance for the use of Wegovy to reduce the risk of significant cardiac difficulties or strokes in adults who are overweight or obese, such as heart attacks or strokes.

The Food and Drug Administration of the United States of America granted sanction for the medicine to be used in specific applications during the month of March.

This resulted in a rise in the number of distinct applications for the highly popular treatment, which coincides with the sector’s increasing level of competition.

On Thursday, Roche, a global pharmaceutical company with its headquarters in Switzerland, announced that its Wegovy competitor weight reduction tablets will be incorporated into a collection of pharmaceuticals designed to mitigate the adverse effects of obesity.

The pharmaceutical collection will encompass a diverse selection of weight loss medications.

The company’s Chief Executive Officer, Thomas Schinecker, conveyed his satisfaction with the exceptional early-stage trial results of the two potential weight-reduction pharmaceuticals that the company is currently developing. In addition, he asserted that these medications demonstrated the “best in disease potential.”

In making this assertion, Schinecker was alluding to the fact that the medications exhibited the “best in disease potential.” He also stated that they will be a part of a more comprehensive portfolio that is intended to set the Swiss company apart from its competitors in the growing obesity therapy market.

This adds insult to injury. This strategy will be implemented in order to distinguish the Swiss company from other businesses in the market.

SOURCE: CNBC

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