Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announces that the FDA granted Fast Track Designation of OKN-007, the proprietary drug for Diffuse Intrinsic Pontine Glioma (DIPG).
The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
With the Fast Track Designation of OKN-007 for the treatment of DIPG, Oblato is eligible for Accelerated Approval and Priority Review and for Rolling Review that allows the Company to submit completed sections of its New Drug Application (NDA) for review by FDA before the entire application can be reviewed. The Company expects that the period of the regulatory approval process will be reduced.
DIPG is a rare pediatric brainstem cancer with limited treatment options. After a DIPG diagnosis, ninety percent of the patients die within 24 months, and the overall 5-year survival is less than one percent.
In addition to the Fast Track Designation, Oblato has already received Rare Pediatric Disease designation for DIPG. The Company is eligible for a rare pediatric disease priority review voucher from the FDA that can be redeemed for a priority review of a marketing application of a different product and is transferrable, when the Company receives NDA approval.
“We anticipate that the Fast Track Designation for DIPG will shorten the NDA review process. The Company will make every effort to develop this treatment for this rare pediatric disease,” stated an official from the Company.
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