Cidara Therapeutics, Inc., a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to its antifungal drug candidate, CD101 IV, for the treatment of candidemia and invasive candidiasis.
Orphan drug designation of CD101 provides Cidara eligibility for seven years of market exclusivity in the United States upon FDA approval, a waiver from payment of User Fees, an exemption from performing clinical studies in pediatric patients, and tax credits for the cost of the clinical research. The seven-year period of marketing exclusivity provided through orphan designation combined with an additional five years of marketing exclusivity provided from the previously announced QIDP designation positions CD101 IV for a total of 12 years of potential marketing exclusivity to be granted at the time of FDA approval.
"This designation underscores the need for new drugs to treat severe fungal infections and is another in a series of milestones that demonstrate the promise of our novel, long-acting echinocandin, CD101 IV," said Jeff Stein, Ph.D., president and CEO of Cidara. "Our phase 1 data demonstrating the safety and tolerability of up to three doses of high exposure, once-weekly CD101 IV enables us to initiate our phase 2 study in candidemia early this year. We believe CD101 IV has the potential to become a best-in-class echinocandin antifungal."
Orphan drug designation of CD101 provides Cidara eligibility for seven years of market exclusivity in the United States upon FDA approval, a waiver from payment of User Fees, an exemption from performing clinical studies in pediatric patients, and tax credits for the cost of the clinical research. The seven-year period of marketing exclusivity provided through orphan designation combined with an additional five years of marketing exclusivity provided from the previously announced QIDP designation positions CD101 IV for a total of 12 years of potential marketing exclusivity to be granted at the time of FDA approval.
"This designation underscores the need for new drugs to treat severe fungal infections and is another in a series of milestones that demonstrate the promise of our novel, long-acting echinocandin, CD101 IV," said Jeff Stein, Ph.D., president and CEO of Cidara. "Our phase 1 data demonstrating the safety and tolerability of up to three doses of high exposure, once-weekly CD101 IV enables us to initiate our phase 2 study in candidemia early this year. We believe CD101 IV has the potential to become a best-in-class echinocandin antifungal."
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