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news.Sirion Therapeutics has received orphan drug designation from the FDA for its anti-viral therapy ganciclovir, for the treatment of acute herpetic keratitis, a leading cause of blindness.
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The product is currently marketed by Laboratoires Thea in Europe under the brand name of Virgan. Sirion licensed the rights to Virgan for the US from Laboratoires Thea in January 2007.
Drugs that receive orphan drug designation obtain seven years of marketing exclusivity from the date of drug approval as well as tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process.
“Topical ganciclovir has been available in Europe for the treatment of ocular viral infections for over 10 years. This product has the potential to advance medical treatment of herpes simplex keratitis in the US,” said Christine Miller, Sirion’s vice president of Regulatory Affairs.