The US Food and Drug Administration ("FDA") recently approved
) Signifor (pasireotide) to treat adults suffering from Cushing's
disease for whom pituitary surgery is not an option or has not
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
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
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
Currently, we have a Neutral recommendation on Novartis.
Novartis carries a Zacks #3 Rank (Hold) in the short run.
However, other pharma companies like
Johnson & Johnson
) carry a Zacks #2 Rank (Buy).
JOHNSON & JOHNS (JNJ): Free Stock Analysis
NOVO-NORDISK AS (NVO): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
To read this article on Zacks.com click here.