Anvisa (National Health Surveillance Agency) granted registration for Sybrava, a new injectable drug manufactured by Novartis and used to control cholesterol. The authorization took place on June 19th.
The drug now passes to the CMED (Chamber of Regulation of the Market for Medicines), the body responsible for defining the maximum prices that medicines can have in the country.
Sybrava has inclisiran as an active ingredient. This substance prevents the production of the PCSK9 protein, which in turn is related to bad cholesterol levels. Therefore, inclisiran also controls cholesterol levels in the body.
The medicine consists of an injection given under the skin of the abdomen by a doctor or other healthcare professional. After three months, a second dose is injected, and consecutive ones are done every six months.
The Sybrava leaflet informs that it is necessary to follow a diet to lower the cholesterol level before taking the injections. It is also recommended to use other drugs used to treat cholesterol – for example, statins. Both measures must be maintained while Sybrava applications are being made.
Children under the age of 18 should not take the drug. People allergic to any of the components should also avoid the drug. Therefore, it is important to consult the leaflet to observe the composition. For pregnant women or those who are breastfeeding, Sybrava can even be used, but it is necessary to have guidance from a health professional for this.
Outside the country, inclisiran has already received authorizations from international regulatory agencies. Novartis disclosed in December 2020 that the product – called Leqvio in other countries – was authorized for the European Union. A year later, in December 2021, it was the FDA, the agency that regulates medicines and food in the US, which granted approval.
A study published in the New England Journal of Medicine in April 2020 investigated the substance’s effect on controlling bad cholesterol. With groups defined between placebo and experimental, the authors concluded that there was a drop of about 50% among participants using inclisiran.
They also mentioned that there was a greater amount of side effects among those who used the drug. In the Brazilian package leaflet, it is said that the drug can cause reactions at the injection site, such as pain and redness, at an average frequency of 10%.
Even so, it is indicated that more serious events may occur because it is a new drug. Seeking medical help and informing the use of the medicine is recommended in these situations.
