FDA rejects orphan status for DUSA drug
DUSA Pharmaceuticals Inc. has failed to receive orphan drug designation from the U.S. Food and Drug Administration for its Levulan Photodynamic Therapy (PDT) system for multiple medical indications, with a concentration on dermatology, the company announced in a news release today. As a result, company president and CEO Robert Doman said that DUSA will close out the pilot clinical trial on solid organ transplant recipients “over the next few months.”
The treatment is intended to prevent skin-related squamous cell carcinomas (SCCs), a form of cancer, in people at risk, such as recipients of solid organ transplants. According to DUSA, although the FDA did note that Levulan could contribute to SCC prevention, the target patients also may have other factors leading to SCCs, which would broaden the pool of potential patients and disqualify a drug cadidate from receiving orphan drug designation.
The FDA grants orphan drug status relating to diseases impacting fewer than 200,000 people in the U.S.
Doman had previously noted that the potential market for Levulan was estimated at $300 million.
Wilmington-based DUSA (Nasdaq: DUSA) was founded in 1988 and went public in 1992. DUSA’s stock dropped almost 12 percent, as of 2:30 p.m. today, to $2.22 per share.