Signifor approved for Cushing's disease

December 17, 2012

(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.

Explore further: EU approves Novartis drug Signifor for Cushing's disease

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

Related Stories

Synribo approved to treat rare leukemia

October 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

December 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

CVS generic competitor to EpiPen, sold at a 6th the price

January 12, 2017

CVS is now selling a rival, generic version of Mylan's EpiPen at about a sixth of its price, just months after the maker of the life-saving allergy treatment was eviscerated before Congress because of its soaring cost to ...

Many misuse OTC sleep aids: survey

December 29, 2016

(HealthDay)—People struggling with insomnia often turn to non-prescription sleep remedies that may be habit-forming and are only intended for short-term use, according to a new Consumer Reports survey.

The pill won't kill your sexual desire, researchers say

December 15, 2016

Taking the pill doesn't lower your sexual desire, contrary to popular belief, according to research published in the Journal of Sexual Medicine. The authors of the research, from the University of Kentucky and Indiana University ...

0 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.