May 3, 2010 / 2:47 PM / 10 years ago

RPT-Takeda blood pressure drug tops rivals in studies

* Takeda drug lowers BP more than Diovan, Benicar

* Takeda’s azilsartan awaiting FDA approval decision

* Analysts see azilsartan sales of $733 mln in 2014

By Bill Berkrot

NEW YORK, May 3 (Reuters) - An experimental hypertension drug being developed by Japan’s Takeda Pharmaceutical Co(4502.T) lowered blood pressure more than two rival medicines from the same class in a pair of late-stage studies.

The Takeda drug, azilsartan medoxomil, which belongs to a class of blood pressure medicines called angiotensin receptor blockers, or ARBs, was tested against the highest doses of Diovan, a big seller for Novartis NOVN.VX, and Benicar, sold by Daiichi Sankyo (4568.T).

Data from the Phase III studies, which were being presented on Monday at the American Society of Hypertension meeting in New York, is part of the package under review by the U.S. Food and Drug Administration. Takeda filed its submission seeking U.S. approval of azilsartan last week.

Analysts polled by Thomson Reuters expect the Takeda drug to reach annual sales of $733 million in 2014 if approved.

One six-week study of 1,291 patients compared the Takeda drug at 40 milligrams or 80 mg with a 40 mg dose of Benicar, known chemically as olmesartan medoxomil, or 320 mg of Diovan, known chemically as valsartan.

The studies evaluated 24-hour mean systolic blood pressure by ambulatory blood pressure monitoring. Systolic is the first, or upper number, in a blood pressure reading.

Azilsartan at 80 mg lowered systolic blood pressure by 14.5 mmHg, while the 40 mg dose took the number down by 13.4 mmHg. Diovan patients saw an average reduction of 10.2 mmHg, while Benicar led to a 12 mmHg reduction.

The difference in reduction between the high dose azilsartan and both rival medicines was considered to be statistically significant, researchers said.

The other six-week study of 1,272 patients tested azilsartan at three doses — 20 mg, 40 mg and 80 mg — against 40 mg of Benicar.

The 80 mg dose of the Takeda drug lowered systolic blood pressure by 13.2 mmHg, while it went down by 12.1 points at 40 mg and 10.8 at 20 mg. That compared to a reduction of 11.2 seen with Benicar.

Once again, the difference between the highest dose of azilsartan and Benicar was considered statistically significant, researchers said.

There was also a statistically significant difference in reduction between 80 mg of azilsartan and 40 mg of Benicar when measuring sitting blood pressure in the clinic — 8.6 mmHg versus 7.1 mmHg, Takeda said.

The most commonly reported adverse side effects from azilsartan were dizziness, increased blood creatine phosphokinase and diarrhea, the company said.

Takeda is hoping the data will not only convince the FDA to approve the drug, but help to differentiate azilsartan in a crowded field of blood pressure lowering medicines.

“We were encouraged at the results demonstrating azilsartan medoxomil achieved greater reductions in 24-hour mean systolic blood pressure when compared to two other commonly used ARBs at their respective maximum doses,” Stuart Kupfer, executive medical director for Takeda clinical science, said in a statement.

Failure to control blood pressure increases the risk of heart attack, stroke and heart failure. (Reporting by Bill Berkrot; Editing by Bernard Orr)

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