Signifor from Novartis approved by FDA

EAST HANOVER, N.J. — Novartis on Tuesday received approval from the Food and Drug Administration for Signifor long-acting release (pasireotide) for injectable suspension, for intramuscular use. The drug is used to treat patients with acromegaly who have had an inadequate response to surgery (and/or for whom surgery may not be an option.) 

 

Acromegaly is an endocrine disorder brought on by elevated growth hormone and insulin-like growth factor-1 levels. Exposure to GH and IGF-1 over prolonged periods of time may lead to extreme physical changes — which includes enlargement of hands, feet and facial features, Novartis stated. The disorder is also asocated with increased mortality rates and such serous health complications as heart disease, hypertension, diabetes and colon cancer. The company noted that heart disease is to blame for approximately 60% of deaths among people suffering form acromegaly. 

 

“The FDA approval of Signifor LAR for acromegaly marks an important day for physicians and patients living with difficult-to-treat pituitary conditions and underscores our continued commitment to helping patients manage rare diseases,” said Bruno Strigini, president, Novartis Oncology. “We are pleased that a new treatment option is now available to help address the serious impact of uncontrolled acromegaly, and are optimistic about providing this much needed treatment to other patients worldwide in the near future.”

 

Signifor has orphan drug designation in the United States.