Novartis hormone disorder drug approved in US
pharmafile | December 16, 2014 | News story | Sales and Marketing | FDA, Lar, Signifor, acromegaly, cushing, hormone, pasireotide
The FDA has approved Novartis’ Signifor (pasireotide) for the treatment of a rare and life-threatening hormonal disorder.
The US Food and Drug Administration has given the treatment the green light to treat patients with acromegaly – an endocrine disorder caused by elevated growth hormone (GH).
The long-acting (LAR) drug has been approved for use with patients who have had a poor response to surgery or if surgery is not an option. After two late-stage studies the drug allowed for greater disease control than existing therapies.
“Treating acromegaly can be extremely challenging and the consequences of inadequate normalisation of hormone levels can be serious for patients,” says Dr Monica Gadelha, of Federal University of Rio de Janeiro and pivotal trial study author.
“With the approval of Signifor LAR, physicians now have a new acromegaly therapy that provides an enhanced mechanism to address elevated hormone levels. This is a significant achievement and much welcomed news for patients with acromegaly.”
First approved in the US in 2012 as a twice-daily subcutaneous injection for Cushing’s disease, the approval of Signifor LAR for Acromegaly now means that patients require just one intramuscular injection a month.
Acromegaly is a rare, debilitating endocrine disorder and in the majority of cases is caused by a non-cancerous tumour on the pituitary gland. Symptoms can include extreme physical changes including the enlargement of hands, feet and facial features.
The erratic disease is also associated with two- to three-fold increased mortality rates and serious health complications, including heart disease, hypertension, diabetes, arthritis and colon cancer.
Bruno Strigini, president of Novartis oncology, says: “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.”
The treatment already has orphan drug designation in the US, plus in November European health regulators approved Signifor for patients in Europe. The Swiss drugmaker has also submitted additional regulatory applications for the medication worldwide.
Tom Robinson
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