The US Food and Drug Administration (“FDA”) recently approved Novartis’ Signifor (pasireotide) to treat adults suffering from Cushing's disease for whom pituitary surgery is not an option or has not been effective.
The approval from the US regulatory body did not come as a surprise as in November this year the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) gave a positive opinion on the use of Signifor as a treatment for Cushing's disease.
The FDA’s decision was based on positive results from the phase III PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease) study. Novartis conducted the study to evaluate the safety and efficacy of Signifor in 162 patients with recurrent Cushing's disease, and newly diagnosed patients with Cushing's disease for whom surgery is not recommended.
Results from the study showed that after treatment with Signifor, patients experienced lower urinary free cortisol (UFC) levels, a measure of disease control. The study also revealed that certain clinical manifestations of Cushing's disease tended towards improvement.
We remind investors that in April this year, Signifor was approved in the EU for the treatment of adults suffering from Cushing's disease who are either ineligible for surgery or have had unsuccessful surgeries. Novartis is currently looking to get the drug approved worldwide.
We are pleased with the US approval of the drug. Signifor, the first FDA approved medicine for the treatment of Cushing's disease, is sure to have a potential market in the US.
Other than Cushing's disease, Novartis is also evaluating Signifor in phase III studies for the treatment of acromegaly syndrome.
Currently, we have a Neutral recommendation on Novartis. Novartis carries a Zacks #3 Rank (Hold) in the short run. However, other pharma companies like Novo Nordisk and Johnson & Johnson carry a Zacks #2 Rank (Buy).