PHARMACY

FDA approves Vivus’ Stendra for erectile dysfunction

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating erectile dysfunction, the agency said Friday.

The FDA announced the approval of Vivus’ Stendra (avanafil).

"This approval expands the available treatment options to men experiencing erectile dysfunction and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs," FDA Office of Drug Evaluation III deputy director Victoria Kusiak said.


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FDA approves GlaxoSmithKline’s Votrient for soft tissue sarcomas

BY Alaric DeArment

PHILADELPHIA — The Food and Drug Administration has approved a drug made by GlaxoSmithKline for certain cancer patients.

GSK announced the FDA approval of Votrient (pazopanib) for patients with soft tissue sarcoma who have received prior chemotherapy.

"It is such a great moment to bring forth this treatment option for patients, as it represents one of the few new medical options to be provided to patients with advanced soft tissue sarcoma over the last 30 years," GSK Oncology president Paolo Paoletti said.

Soft tissue sarcomas are a group of rare cancers that affect the mesenchymal cells, which give rise to soft tissues, such as muscles, nerves, fat, blood vessels and others. The incidence of STS was 10,980 in 2011, according to the American Cancer Society.


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FDA approves Novartis drug for tumors in patients with rare genetic disease

BY Alaric DeArment

EAST HANOVER, N.J. — A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

The FDA approved Afinitor (everolimus) tablets for treating the tumors, known as renal angiomyolipomas, in adults with TSC who don’t require surgery. The drug already was approved to treat brain tumors known as subependymal giant cell astrocytoma, or SEGA, in patients with TSC.

The tumors occur in up to 80% of people with the disease, which affects between 25,000 and 40,000 people in the United States. TSC, a genetic disorder, can affect various parts of the body and causes disorders, such as skin lesions, seizures, brain swelling, kidney failure, developmental delays and behavioral problems. Onset typically occurs between the ages of 15 and 30 years, and the tumors can grow large enough to cause severe internal bleeding.

"Renal angiomyolipomas are one of the greatest causes of morbidity and mortality in adult TSC patients and can be one of the most challenging aspects of the disease to treat," Cincinnati Children’s Hospital Medical Center nephrology chairman John Bissler said. "Today marks an important step for the TSC community, as Afinitor is now the only approved medicine to reduce the kidney tumor burden in these patients."


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