The FDA gave the green light for AstraZeneca’s Brilinta, a drug known for its blood thinning properties to be used for U.S. patients having a heart attack history.
The FDA approval is expected to boost the selling of Brilinta to a staggering 3.5 billion dollars yearly, bringing it close to targets set by AstraZeneca CEO. While the drug was used for the same purpose until now, the previous FDA approval envisioned a higher dose over a period of 12 months being prescribed to patients who had suffered a heart attack.
With the new approval, it is expected that the number of patients who are eligible for treatment with Brilinta will double. Nonetheless, it is possible that restrictions will be set in place with view to high risk patients, particularly those at high risk of bleeding complications or cardiac complications.
Brilinta is used a post-heart attack drug that lowers the risk of developing blood clots by thinning the blood. Blood clots could lead to other heart attacks, as well as strokes which are deadly. With the new FDA approval, the AstraZeneca drug could be used in combination with the COX inhibitor aspirin in a 60 mg dose. At the same time, the period of treatment with Brilinta increases over the previously set limit of one year.
The approval of Brilinta for a prolonged treatment for U.S. patients who have suffered a heart attack is in line with the shift in the European market as well. Here, the use of Brilinta beyond the one-year limit has been discussed during the previous week.
So far, no time limitation has been set on the use of Brilinta. However, according to vice president overseeing Brilinta with AstraZeneca, Tom Keith-Roach, the green light received from the FDA signals a shift in the market. The trend should shift among doctors as well, as clinical practices are increasingly inclining toward long-term drug treatments.
In the United States, approximately a quarter of all patients who suffered a heart attack and are treated with Brilinta, as well as other blood-thinners remain on the treatment for the full 12 month period. The trend is similar in Europe.
“We’re not going to see fireworks but this will support really strong and consistent growth over time. I’ve got a nice straight line that goes from our current reported sales to my $3.5 billion”,
Currently, the British drugmaker is planning to expand the uses of Brilinta for diabetes, peripheral arterial disease and stroke treatment applications.
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