The FDA has set a PDUFA target action date of 28 August 2024 for the investigational, Aldose Reductase Inhibitor
FDA grants priority review for govorestat in classic galactosemia. (Credit: Sam Moghadam Khamseh on Unsplash)
Applied Therapeutics has secured priority review from the US Food and Drug Administration (FDA) for govorestat (AT-007) in the treatment of classic galactosemia.
The FDA has set a Prescription Drug User Free Act (PDUFA) target action date of 28 August 2024.
Additionally, the FDA intends to have a meeting of the advisory committee to discuss the NDA.
Applied Therapeutics founder and CEO Shoshana Shendelman said: “The FDA’s acceptance of the NDA for govorestat for the treatment of Galactosemia represents a critical milestone for Applied Therapeutics and more importantly, for patients with Galactosemia and their families.
“The Agency’s decision to grant Priority Review for this NDA underscores the urgent unmet medical need as there are currently no treatment options for this devastating disease.”
Govorestat is an investigational, Aldose Reductase Inhibitor (ARI). It is being developed to treat various rare diseases.
Previously granted paediatric rare disease designation in the US, govorestat will be eligible for a priority review voucher (PRV) following its approval.
Additionally, Applied Therapeutics has applied for a marketing authorisation application (MAA) with the European Medicines Agency (EMA) for govorestat for classic galactosemia.
The MAA was validated in December 2023 and is currently being reviewed by the EMA’s Committee for Medicinal Products for Human Use.
Applied Therapeutics anticipates a decision on the MAA from the EMA in Q4 2024.
Concurrently, the clinical-stage biopharmaceutical company announced a securities purchase agreement for a private placement of $100m of equity.
Applied Therapeutics entered into an agreement for the sale of around 12.3 million shares of its common stock and two million pre-funded warrants to buy common stock at a purchase price of nearly $7.
The net proceeds will be utilised by the company to finance commercial activities related to govorestat, explore additional pipeline candidates, and provide work capital for general corporate needs.
Applied Therapeutics will likely be funded through 2026 by the capital raised in the private placement, existing cash flow, and anticipated milestones from its licence agreement with Advanz Europe.