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# Accelerated Approval Pathway Possible for Emphysema Drug
- URL: https://www.fdaweb.com/accelerated-approval-pathway-possible-for-emphysema-drug/
- Published: 2022-10-04T12:00:00.000Z
- Updated: 2026-09-14T18:01:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152882

FDA has told Inhibrx that there is potential to pursue an accelerated approval for INBRX-101, an optimized recombinant human AAT-Fc fusion protein, for treating patients with emphysema due to alpha-1 antitrypsin deficiency (AATD). The accelerated pathway would rely on “functional alpha-1 antitrypsin (AAT) serum levels as the surrogate endpoint,” according to the company.

It says it plans to begin a potential registration-enabling clinical trial evaluating functional AAT in the first quarter of next year. FDA expressed support to collaborate and work with Inhibrx to address the regulatory challenges associated with AATD drug development,” it says. “The FDA emphasized the importance of being able to demonstrate INBRX-101’s ability to maintain a trough level within the normal range of AAT in healthy individuals. Based on data from the completed Phase 1 study of INBRX-101, the dosing of INBRX-101 every three or four weeks in patients with AATD is predicted to maintain patients above the lower threshold of the normal range and achieve an average level of functional AAT that approximates that of healthy non-deficient (MM genotype) adults.”

The agency also requested additional data on the correlation between functional AAT levels and the clinical benefit in AATD to further support serum AAT levels as a surrogate endpoint, the company says. “Inhibrx intends to collaborate with experts in the field and the Alpha-1 Foundation to illustrate, based on existing registry, health records and published data, that increased functional AAT levels are reasonably likely to predict clinical benefit in AATD patients,” it says.