Santarus says FDA accepts Ruconest application
Santarus and Pharming say FDA accepts new Ruconest application; decision due in April
NEW YORK (AP) -- Santarus Inc. and Pharming Group said Tuesday that the Food and Drug Administration accepted their marketing application for the hereditary angioedema drug Ruconest, and will make a decision in 10 months.
The companies want to market the drug as a treatment for acute attacks of hereditary angioedema, a rare genetic disorder that can cause dangerous swelling of the throat or larynx.
They say the FDA plans to have one of its advisory committees review the application and expects to make a decision on the drug by April 16, 2014.
Ruconest was developed by Pharming, and Santarus has the right to market the drug in North America. The drug was approved in Europe in 2010 under the name Rhucin.
The companies also filed for FDA approval in 2010, but the agency refused to accept the application. Among other problems the agency said the drug had not been tested on enough patients at the dose the companies were proposing. Since then the companies have run another late-stage trial of Ruconest.
Shares of Santarus rose 30 cents to $21.82 in midday trading. Its shares have traded between $4.82 and $24 over the past year.
