Signifor approved for Cushing's disease

(HealthDay)—Signifor (pasireotide diaspartate) has been approved by the U.S. Food and Drug Administration to treat Cushing's disease in cases that cannot be treated by surgery.

Cushing's occurs when the body overproduces cortisol, a hormone made by the . Cortisol helps regulate the body's reaction to stress and injury. People with Cushing's may be overweight, glucose intolerant, diabetic, have high blood pressure, bruise easily and be at increased risk of infection, the agency said in a news release.

Signifor was evaluated in a clinical study of 162 people with Cushing's disease, and a reduction in cortisol production was seen in as little as one month. About 20 percent of people had cortisol levels within the normal range by the end of the six-month study, the FDA said.

The most common adverse reactions to the twice-daily injected drug included , diarrhea, nausea, abdominal pain and gallstones.

The agency said it is requiring the drug's Swiss maker, Novartis, to conduct three post-approval studies to evaluate Signifor's effects on factors including high blood sugar management, and the potential for acute and adrenal insufficiency.

More information: Medline Plus has more about Cushing's disease.

add to favorites email to friend print save as pdf

Related Stories

Synribo approved to treat rare leukemia

Oct 26, 2012

(HealthDay)—Synribo (omacetaxine mepesuccinate) has been approved by the U.S. Food and Drug Administration to treat a rare blood and bone marrow disease called chronic myelogenous leukemia (CML).

Iclusig approved for rare leukemias

Dec 16, 2012

(HealthDay)—Iclusig (ponatinib) has been approved by the U.S. Food and Drug Administration to treat two rare forms of leukemia..

Recommended for you

Medical charity warns India over patent rules

Jan 21, 2015

Doctors without Borders on Wednesday warned the Indian government not to bow to US pressure to amend patent regulations that allow millions access to affordable medicines, ahead of a visit by President Barack Obama.

Why are some generic drugs getting so expensive?

Jan 21, 2015

More than eight out of every 10 prescriptions dispensed in the US is generic. This growth is due to a large number of top-selling drugs going off patent over the past decade, as well as innovations in t ...

Supreme Court sides with Teva in drug dispute

Jan 20, 2015

The Supreme Court on Tuesday sided with Teva Pharmaceutical Industries Ltd. in the company's high-profile patent dispute with rival firms over the top-selling multiple sclerosis drug.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.