Aldeyra receives PDUFA date for reproxalap, expands AbbVie option agreement
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Key takeaways:
- The PDUFA date for the resubmitted new drug application is April 2, 2025.
- Aldeyra has expanded an exclusive option agreement with AbbVie.
The FDA has accepted the resubmitted new drug application for reproxalap, an investigational treatment for dry eye disease, and assigned a Prescription Drug User Fee Act date, according to a press release from Aldeyra Therapeutics.
The new PDUFA date has been set for April 2, 2025. As Healio previously reported, the FDA did not approve Aldeyra’s initial submission for reproxalap.
In addition, the company reported the expansion of its exclusive option agreement with AbbVie, which grants AbbVie the option to obtain a co-exclusive license to develop, manufacture and commercialize reproxalap in the U.S. AbbVie would pay Aldeyra $100 million in cash upfront upon exercising the option, making Aldeyra eligible to receive up to $300 million in regulatory and commercial milestone payments.
The expansion allows Aldeyra to initiate “certain precommercial activities, 60% of which will be paid by AbbVie and 40% of which will be paid by Aldeyra if the option is exercised,” the release said. Aldeyra would also share profits and losses for the treatment with AbbVie, with a split of 60% for AbbVie and 40% for Aldeyra.
“Based on the FDA’s acceptance of the NDA resubmission of reproxalap for dry eye disease for review, we are pleased to announce an expansion of our option agreement with AbbVie, highlighting the commitment of both companies to accelerating the potential availability of a novel dry eye disease therapy to patients and physicians,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, said in the release.
The companies have amended the expiration of the option to 10 business days from the date of FDA approval.
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