The US Food and Drug Administration (FDA) granted Orphan Drug designation for Insys Therapeutics’ ovarian cancer candidate.
The agency granted the designation to Insys’ Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer. The FDA’s Office of Orphan Products Development grants novel drugs or biologics that treat rare diseases or conditions, affecting fewer than 200,000 people in the US. If approved, Insys will receive a seven-year period of US marketing exclusivity, as well as certain financial incentives to help support the drug’s development.
Ovarian cancer is a disease in which malignant or cancerous cells are found in the tissues of the ovary. It is the leading cause of death from gynecologic cancers in the US, and is the fifth leading cause of cancer death among women in the US. In 2014, an estimated 21,980 new cases of ovarian cancer were diagnosed and an estimated 14,270 people died from ovarian cancer in the US.
“We are pleased to have received orphan drug designation for LEP-ETU to treat ovarian cancer, a devastating and difficult-to-treat disease,” said Michael L. Babich, President and Chief Executive Officer. “By entrapping the paclitaxel with liposomes, we believe our LEP-ETU formulation could potentially have reduced toxicity, while maintaining or enhancing efficacy of the cancer-fighting paclitaxel. We are currently evaluating next steps with respect to this drug product candidate.”
Paclitaxel is an anti-microtubular network agent and is active in a broad spectrum of malignancies. It has poor solubility. In order to enhance this, paclitaxel is formulated with or bound to a delivery vehicle. LEP-ETU is an improved formulation of paclitaxel, which is a chemotherapeutic agent that is widely used. The candidate has already received FDA orphan drug designation for the potential treatment for patients with gastric cancer.
Insys acquired LEP-ETU during in 2010 through its merger with NeoPharm.
Source: Insys Therapeutics, Inc.