Aug 2 Bayer AG's experimental blood
pressure drug worked well in clinical trials and should be
approved, but at lower doses, medical reviewers at the U.S. Food
and Drug Administration concluded.
The reviewers posted their report on the agency's website in
preparation for a meeting on Tuesday of outside medical experts
who will discuss the findings and recommend whether the FDA
should approve the drug.
The drug is designed to improve exercise capacity in
patients with chronic thromboembolic pulmonary hypertension, or
CTEPH, who cannot be operated on or who continue to suffer from
the condition after surgery.
The drug is also being developed to improve exercise
capacity for patients with pulmonary arterial hypertension, or
PAH, and to delay worsening of the condition.
The primary safety concerns relate to bleeding, low blood
pressure and possible impact on kidney function in some
patients. The reviewers said the drug can cause birth defects
and a risk-management program would need to be implemented.