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

Study recalculates costs of combination vaccines

Apr 17, 2014

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive ...

Drug watchdog urges vigilance in cancer drug theft

Apr 17, 2014

Europe's medicine watchdog urged doctors Thursday to be vigilant in administering the cancer drug Herceptin, vials of which had been stolen in Italy and tampered with before being sold back into the supply chain.

User comments