logo
Share SHARE
FONT-SIZE Plus   Neg

Novartis Says EC Oks Signifor To Treat Adult Patients With Cushing's Disease

Novartis (NVS) said that the European Commission has approved Signifor (pasireotide) for the treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed. Signifor is the first medicine to be approved in the European Union targeting Cushing's disease, a disorder caused by excess cortisol in the body due to the presence of a non-cancerous pituitary tumor.

The decision follows the positive opinion the Committee for Medicinal Products for Human Use adopted for Signifor in January 2012 for the treatment of Cushing's disease and applies to all 27 EU member states, plus Iceland and Norway.

The company noted that the approval is based on data from the largest randomized Phase III study to evaluate a medical therapy in patients with Cushing's disease. In the study, majority of patients experienced a rapid and sustained decrease in mean cortisol levels with a subset of patients achieving normalization. Mean urinary-free cortisol (UFC) levels were normalized in 26.3% and 14.6% of the 162 patients randomized to receive Signifor 900µg and 600µg subcutaneous injection twice daily, respectively, at month six. The primary endpoint, the proportion of patients who achieved normalization of UFC after six months without dose up-titration relative to randomized dose, was met in patients treated with 900µg twice daily.

In addition, the study showed the majority of the patients remaining on the study at month six had any reduction in their mean UFC. The median reduction in mean UFC was 47.9% in both dose groups.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
General Electric Company (GE) reported second-quarter industrial operating plus verticals EPS (Non-GAAP) of $0.28, a decrease of 45% over prior year. On average, 14 analysts polled by Thomson Reuters expected the company to report profit per share of $0.25 for the quarter. Analysts' estimates typically... Belgian brewer Anheuser-Busch InBev NV or AB InBev on Thursday said it is acquiring Hiball Inc., a San Francisco-based maker of organic energy drinks and carbonated juices and water. The company did not disclose the terms of the deal. Denver, Colorado based low-cost carrier Frontier Airlines will expand its services to 21 cities. The airline which serves 80 cities in the U.S., Mexico and the Dominican Republic is planning to add 85 new routes.
comments powered by Disqus
Follow RTT