FDA gives Lymphoseek orphan drug status

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Navidea Biopharmaceuticals' Lymphoseek radiopharmaceutical agent for use in sentinel lymph node detection in patients with head and neck cancer.

The designation is based on an estimated 40,000 procedures being done in this patient population, according to Navidea.

The FDA program provides a special status to drugs and biologics intended to treat, diagnose, or prevent rare or "orphan" diseases and disorders, defined as affecting fewer than 200,000 people in the U.S.

The designation provides for a seven-year marketing exclusivity period against competition in head and neck cancers, as well as certain incentives, including federal grants, tax credits, and a waiver of certain filing fees, which qualifies the company to request a refund of previously paid filing fees of up to $1.1 million.

Lymphoseek was approved by the FDA in June to be used to help asses the extent to which squamous cell carcinoma has spread in the head and neck. In 2013, it was approved for identifying lymph nodes closest to a primary tumor in patients with breast cancer or melanoma.

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