Novartis Receives EU Approval for SigniforBy
Novartis reports that the European Commission has approved Signifor (pasireotide) as a new long-acting release formulation for once monthly intramuscular injection to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue (SSA). Next-generation SSA Signifor offers an alternative treatment option directly targeting the pituitary tumor for patients whose acromegaly remains inadequately controlled on currently available SSAs. Acromegaly affects an estimated one to two in every 10,000 people in the European Union (EU).
The approval in the EU follows a positive opinion adopted by the Committee for Medicinal Products for Human Use in September 2014 for Signifor for the treatment of acromegaly and applies to all 27 EU member states, plus Iceland and Norway. Additional regulatory applications for the new long-acting release formulation of Signifor have been filed worldwide for the treatment of acromegaly, including an application currently filed in the United States. In the EU, Signifor has orphan drug designation for acromegaly. Orphan drugs are those that treat a condition which affects no more than five in 10,000 people in the EU.