United Theraputics' pulmonary hypertension drug passes FDA requirements with flying colors
SILVER SPRING, Md. United Therapeutics has said that the final human testing of an inhaled form of its lead drug, a treatment for pulmonary hypertension, exceeded the minimal requirements set by the Food and Drug Administration, according to the Washingtonpost.com.
The drug, Remodulin, treats the rare condition of dangerously high blood pressure in arteries between the heart and lungs. The drug is taken either intravenously or via an injection, but its new form, Viveta is inhaled four times daily for a few minutes.
The testing showed that patients who had been tested before and then after 12 weeks of taking the drug improved the distance they could walk by average of 20 meters. “These are amazing results,” said Martine Rothblatt, the company’s chief executive. “We are just absolutely elated.” While 20 meters may not seem like a lot, Rothblatt, whose daughter suffers from the disease, said it is a huge difference to patients with the disease. “These patients cannot walk up one flight of steps,” she said.
The company as a result of this news, reported a third-quarter profit that increased 74 percent, to $14.8 million.