QLT (QLTI) Gets Fast Track from FDA for QLT091001 as LCA Treatment
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QLT Inc. (Nasdaq: QLTI) reports it's oral synthetic retinoid for retinal diseases, QLT091001, has been granted two Fast Track designations by the U.S. Food and Drug Administration (FDA) for the treatment of Leber Congenital Amaurosis (LCA) due to inherited mutations in LRAT and RPE65 genes and for the treatment of autosomal recessive Retinitis Pigmentosa (RP) due to inherited mutations in LRAT and RPE65 genes.
The FDA's Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended for the treatment of serious diseases and fill an unmet medical need.
Following the recent completion of the QLT091001 Phase 1b trial in the LCA cohort, the Company continues the ongoing follow-up and initial re-treatment of LCA patients, as well as targeting the completion of subject enrollment in the RP cohort before the end of 2011.
QLT received clearance from the FDA in July 2011 of our Investigational New Drug Application (IND) for QLT091001 allowing the Company to proceed with investigator sites in the U.S. for LCA and RP patients. Also in July, QLT received clearance from the U.K. Medicines and Healthcare Products Regulatory Agency of our Clinical Trial Application (CTA) for QLT091001 allowing the Company to proceed with investigator sites in that jurisdiction for LCA and RP patients.
The FDA's Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended for the treatment of serious diseases and fill an unmet medical need.
Following the recent completion of the QLT091001 Phase 1b trial in the LCA cohort, the Company continues the ongoing follow-up and initial re-treatment of LCA patients, as well as targeting the completion of subject enrollment in the RP cohort before the end of 2011.
QLT received clearance from the FDA in July 2011 of our Investigational New Drug Application (IND) for QLT091001 allowing the Company to proceed with investigator sites in the U.S. for LCA and RP patients. Also in July, QLT received clearance from the U.K. Medicines and Healthcare Products Regulatory Agency of our Clinical Trial Application (CTA) for QLT091001 allowing the Company to proceed with investigator sites in that jurisdiction for LCA and RP patients.
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