FDA grants fast track designation to oral molecule for retinopathy of prematurity
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Key takeaways
- The ruling will expedite the review process for the oral molecule.
- The company plans to begin a phase 1b/2 study of FLQ-101 in 2025.
The FDA granted fast track designation to FLQ-101 for the treatment of retinopathy of prematurity, according to a press release from FELIQS.
FLQ-101 is a once-daily oral and intravenous solution designed to mitigate inflammation and abnormal neovascularization in the retina by spurring the physiologic response of vascularization. The FDA’s ruling will expedite the review process for treatments that show promise in addressing unmet needs in severe conditions.
"The fast track designation is indicative of the unmet clinical need in addressing the societal and patient-level importance of prevention of the development of both ROP and treatment warranted ROP,” Darius M. Moshfeghi, MD, of Byers Eye Institute, told Healio. “This is a major milestone for FELIQS and the field.”
FLQ-101 received orphan drug designation earlier this year, and the company is preparing to begin a phase 1b/2 study of the therapeutic in the U.S. and Japan in 2025.
“With no approved preventative treatments available for retinopathy of prematurity, receiving the fast track designation for FLQ-101 is an important milestone for our company,” Ken-ichiro (Nobu) Kuninobu, PhD, RPh, co-founder and CEO of FELIQS, said in the release. “This designation will facilitate the review process and give us better access to the FDA which should shorten the clinical development program timeline and improve the chances of designing and conducting a successful program. We are excited that the FDA recognized the unmet medical need in the target population and that FLQ-101 could potentially close this gap.”
FELIQS also plans to submit an investigational new drug application for FLQ-104, a therapy for the treatment of intermediate dry age-related macular degeneration, next year.
Editor’s Note: This article was updated on Nov. 5, 2024, to add comments from Darius M. Moshfeghi, MD.
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