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# Reg Review Period for Alnylan’s Givlaari
- URL: https://www.fdaweb.com/reg-review-period-for-alnylans-givlaari/
- Published: 2021-06-22T12:00:00.000Z
- Updated: 2026-09-14T17:04:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149587

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Alnylam Pharmaceuticals’ Givlaari (givosiran), indicated for treating adults with acute hepatic porphyria. The regulatory review period is 1,533 days, which includes 1,363 days that occurred during the testing phase and 170 days during the approval phase. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-13176.pdf?ref=fdaweb.com).