FDA Approves Novartis' Signifor LAR For Acromegaly

Novartis announced the approval of the U.S. Food and Drug Administration (FDA) for its drug Signifor (pasireotide) long-acting release (LAR) as treatment for endocrine disorder acromegaly.

Signifor is an SSA administered, once-monthly drug that binds to somatostatin receptors (SSTRs) to help inhibit secretion of biochemicals that drive the progression of acromegaly. The FDA granted Orphan Drug Designation for Signifor as potential treatment for acromegaly.

Acromegaly is a rare, disabling endocrine disorder resulting from excessive production of growth hormone (GH) and insulin-like growth factor (IGF-1). The disorder is characterized by abnormal enlargement of facial features, hands, and feet. Acromegaly is linked with a two- to three-fold increase in mortality rates and serious complications, such as hypertension, diabetes, and heart disease. Heart disease in particular is responsible for around 60 percent of acromegaly patients’ deaths.

The FDA approved Signifor LAR as an injectable suspension for intramuscular use to treat patients with acromegaly who failed to have an adequate response to surgery or are not qualified for surgery. The decision was based on positive results from two multicenter Phase 3 studies, which showed that the drug achieved higher rates of full biochemical control compared to a first generation SSA.

Dr. Monica Gadelha, Professor, Federal University of Rio de Janeiro and author of the pivotal trial for the drug, said, “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.”

Bruno Strigini, president, Novartis Oncology, said, “The FDA approval of Signifor LAR for acromegaly marks an important day for physicians and patients living with difficult-to-treat pituitary conditions… We are pleased that a new treatment option is now available to help address the serious impact of uncontrolled acromegaly, and we are optimistic about providing this much needed treatment to other patients worldwide in the near future.”

The drug was approved last month for the treatment of acromegaly in the EU following the positive opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).