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Novagali Pharma granted FDA orphan drug designation for vernal keratoconjunctivitis drug
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EVRY, France — Novagali Pharma received orphan drug designation from the U.S. Food and Drug Administration for Vekacia, a cationic emulsion of cyclosporine A, for treating vernal keratoconjunctivitis, the company announced in a press release.
The orphan drug designation grants Novagali 7 years of marketing exclusivity from the date of drug approval. It also provides for tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process.
Novagali previously received orphan drug designation for Vekacia from the European Medicines Agency in March 2006.
In April, the company announced positive results from a phase 3 clinical study involving children. In the study, investigators found that Vekacia improved symptoms and signs of disease and that the drug was safe and well tolerated, according to the press release.
Novagali plans to file for European Marketing Authorization later this year, the release said.