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.
N.J. Rep. criticizes FDA over weaker antidepressant warnings for children
WASHINGTON Rep. Mike Ferguson, R-N.J., is criticizing the Food and Drug Administration, for its revised antidepressant medication guides because the warnings for children take the medications have been weakened compared to the old guide.
Ferguson said the guides include more generalized information regarding the risks for children, teenagers and young adults taking antidepressants. He also stated that the new guides use a generic warning that combines all three age groups into one category and abbreviates safety information.
In October 2003, the FDA issued an advisory warning of the increased risk of suicide in pediatric patients taking selective serotonin reuptake inhibitors for depression. After reviewing more data from pediatric studies, the agency told antidepressant manufacturers to revise their product labeling to include the risk of suicide in children and adolescents.
Herbert Luther appointed Perrigo’s VP of global regulatory affairs
ALLEGAN, Mich. Perrigo has announced that Herbert Luther will become the company’s vice president, global regulatory affairs.
In this role, Luther will be responsible for developing and executing regulatory-submission strategies, ensuring best practices, and implementing technologies to enhance efficiency.
Luther has over 20 years experience in the development of regulatory and clinical strategies. Before joining Perrigo, he worked at KV Pharmaceuticals, where he was vice president of regulatory/clinical affairs. Before that, he served as director of regulatory affairs at Barr Laboratories.