File photo: AstraZeneca campus in Mölndal, Sweden (2016). Bjoertvedt / Wikimedia Commons, CC BY-SA 4.0. Cropped and resized; this image adaptation is licensed under CC BY-SA 4.0.
AstraZeneca’s blood-pressure pill Baxfendy has cleared a European regulatory step for adults whose hypertension remains too high despite taking at least two medicines.
The European Medicines Agency’s human medicines committee recommended granting the drug a marketing authorisation on November 12. AstraZeneca announced the recommendation Friday. It is a positive opinion, not a final European Union approval: the European Commission’s decision is still pending.
The proposed use is specific. Baxfendy, also called baxdrostat, would treat adults whose blood pressure is not adequately controlled with at least two blood-pressure medicines. It is not a recommendation to replace those medicines or change treatment without a clinician.
Blocking a hormone that raises pressure
Baxdrostat blocks an enzyme needed to make aldosterone, a hormone that encourages the kidneys to retain salt and water. That can increase blood volume and raise blood pressure.
The EMA’s assessment summary says randomised, double-blind, placebo-controlled studies showed meaningful reductions in both the upper and lower blood-pressure readings among patients already taking at least two blood-pressure medicines.
The agency identifies high blood potassium, called hyperkalaemia, as the most common side effect. Its detailed prescribing recommendations will be published after a European Commission authorisation, if granted.
What the trial numbers measure
In the BaxHTN trial, the 2-milligram dose reduced the upper blood-pressure reading measured in a clinic by 15.7 millimetres of mercury from the starting level at 12 weeks. The reduction beyond the change seen with placebo was 9.8 millimetres of mercury, according to AstraZeneca’s announcement.
A separate trial, Bax24, measured blood pressure over a full day rather than only in a clinic. The 2-milligram dose reduced the average 24-hour upper reading by 16.6 millimetres of mercury from the starting level at 12 weeks, or 14.0 millimetres of mercury more than placebo.
Those are different measurements in different trials. The larger fall from a patient’s starting level is not the same as the drug’s additional effect compared with placebo. Participants received the study drug or placebo on top of their existing treatment.
The current news is the European committee’s recommendation, not the release of new trial results. The next regulatory step is the Commission’s decision on whether to authorise the medicine for the proposed adult population.
JBizNews Desk | New York
© JBizNews.com. All rights reserved. Unauthorized reproduction or redistribution is strictly prohibited.
