By Neil Maclucas
ZURICH--Novartis AG (NVS) said Tuesday its Signifor injectable
drug has received U.S. regulatory approval for treating patients
with a life-threatening hormonal disorder.
Basel-based Novartis said the U.S. Food and Drug Administration
had approved long-acting-release Signifor for use in treating
acromegaly patients who have either failed to respond to surgery,
or for whom surgery isn't an option. The approval comes after two
late-stage studies demonstrated the drug provided better disease
control than existing therapies.
Acromegaly is a rare disorder caused by the over production of
growth hormones, often originating from a benign tumor on the
pituitary gland. Roughly 60 in one million people are estimated to
develop acromegaly.
Novartis last month received Signifor approval from European
regulators for treating the same hormonal disorder.
Write to neil.maclucas@wsj.com
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