SillaJen's 'Pexavac' Designated as Orphan Drug by US FDA

[Asia Economy Reporter Cho Hyun-ui] ShillaJen's immuno-oncology drug candidate 'Pexa-Vec' has been designated and approved by the U.S. Food and Drug Administration (FDA) as an orphan drug for the treatment of stage IIB-IV (stage 2) melanoma.

According to ShillaJen on the 27th, the designation of Pexa-Vec as an orphan drug refers to high-risk melanoma at stages IIB-IV.

With the orphan drug designation, ShillaJen is eligible to apply for benefits such as a 7-year market exclusivity period from the date of approval, a 50% tax credit on clinical trial costs in the U.S., and expedited FDA new drug approval review periods.

Melanoma, commonly known as skin cancer, can occur anywhere melanocytes are present. Among cancers occurring on the skin, it has the highest malignancy but often shows no subjective symptoms and may appear as ordinary moles or nodules.

A ShillaJen official stated, "Being designated as an orphan drug during the development stage reflects a high evaluation of the medical importance, safety, and potential of the product," and added, "We will strive to produce positive results in the various ongoing clinical trials by leveraging this orphan drug designation as a stepping stone."