EU approves Novartis drug Signifor for Cushing's disease

European Union regulators have given Swiss pharmaceutical group Novartis a green light to market its drug Signifor as a treatment for Cushing's disease, the company said Wednesday.

The group said it was the first time the EU has approved a drug to treat the , which is caused by a tumour or growth on the pituitary gland and is generally treated surgically.

"The European Commission has approved Signifor (pasireotide) for the treatment of with Cushing's disease for whom surgery is not an option or for whom surgery has failed," Novartis said in a statement.

Cushing's disease causes fatigue, depression, , upper-body obesity and a reddened moon face.

The approval follows phase-three clinical trials that found Cushing's patients who received two daily injections of Signifor for six months had reduced levels of cortisol, a stress hormone present in above-normal quantities in people with the disease.

Cushing's affects between one and two people per million each year.

Analysts at Zurich state-owned bank ZKB estimated 20,000 European patients could be treated with Signifor, generating potential sales of some $700 million (529.3 million euros) for Novartis over five years.

add to favorites email to friend print save as pdf

Related Stories

Recommended for you

Determine patient preferences by means of conjoint analysis

1 hour ago

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

User comments