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

Editors Pick
Baker Hughes Inc.'s shares gained around 7 percent in the extended trading on Thursday after conglomerate General Electric Co. confirmed, while responding to media reports, that it is in talks to buy the oilfield services provider. The stock is moving 6 percent ahead in the pre-market activity. Shares of Sanofi were gaining around 7 percent in the morning trading in Paris after the French drug maker on Friday raised its 2016 business earnings guidance, after it reported strong third-quarter results. In addition, the company set a 3.5 billion euros share repurchase program to be completed by the end of 2017. Swiss banking giant UBS Group AG (UBS) reported Friday an increased pre-tax profit for the third quarter despite weakness in net interest income. Net profit, however, decreased on the absence of last year's hefty tax benefit. Looking ahead, UBS said it is unlikely that the underlying macroeconomic uncertainty and geopolitical tensions will change in the foreseeable future.
comments powered by Disqus
Follow RTT