SKYRIZI

批准信原文要点

This Prior Approval sBLA provides for the following changes for risankizumab-rzaa: alternative subcutaneous induction dosing regimen for moderately to severely active Crohn's disease in adults, and to update to the language related to Tuberculosis evaluation and monitoring in the USPI and Medication Guide.

批准信原文要点

These Prior Approval sBLAs provide for: BLA 761105/S-045: Expansion of the psoriatic arthritis indication to include pediatric patients 6 years of age and older. BLA 761262/S-016: Labeling changes to align and harmonize the prescribing information between the two BLAs.

批准信原文要点

These Prior Approval sBLAs provide for: BLA 761105/S-044: the use of risankizumab 55 mg/0.37 mL pre-filled syringe (PFS) to support expansion for use in pediatric patients 6 years of age and older in plaque psoriasis by subcutaneous injection. BLA 761262/S-015: companion labeling for Skyrizi (risankizumab-rzaa) for intravenous injection.

批准信原文要点

This Prior Approval sBLA provides for updates to the Instructions for Use (IFU) for the On-Body Injector 180 mg/1.2 mL Prefilled Cartridge and On-Body Injector and 360 mg/2.4 mL Prefilled Cartridge to improve clarity of the instructions and emphasize steps important to the functionality of the device.

批准信原文要点

BLA 761105/S-042: updates to the United States Physicians Insert (USPI) with the results from clinical trial, M23-702, evaluating treatment of plaque psoriasis involving the genital and scalp areas

批准信原文要点

These Prior Approval supplemental biologics license applications provide for a new presentation of a 180 mg/1.2 mL (150 mg/mL) needlestick protection device-prefilled syringe (NSP-PFS) for subcutaneous maintenance dosing in the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adult patients.

批准信原文要点

These Prior Approval supplemental biologics license applications provide for the addition of an indication of the treatment of moderately to severely active ulcerative colitis in adults.

批准信原文要点

These Prior Approval supplemental biologics applications provide for the addition of two new presentations and packaging to allow patient subcutaneous self-administration of the recommended maintenance dosage for the treatment of moderately to severely active Crohn's disease (CD) in adults

批准信原文要点

These Prior Approval supplemental biologics applications provide for changes to the Prescribing Information to add 0.9% Sodium Chloride as a diluent ... section 2.7 ... and addition of information on the lack effect of risankizumab-rzaa on the metabolism of various CYPP450 substrates ... section 12.3 ... PMC 4294-7.

批准信原文要点

This Prior Approval supplemental biologics license application provides for the treatment of moderately to severely active Crohn’s disease in adults.

批准信原文要点

This Prior Approval supplemental biologics license application provides for the treatment of moderately to severely active Crohn’s disease in adults.

批准信原文要点

This Prior Approval supplemental biologics license application provides for use of Skyrizi in the treatment of active psoriatic arthritis (PsA) in adults.

批准信原文要点

This Prior Approval supplemental biologics application provides for a change to a new 150 mg/mL formulation and product presentation (pre-filled syringe with needle stick prevention) in S-009. The purpose of the supplemental BLA (sBLA) S-010 is to propose a new autoinjector product presentation using the 150 mg/mL formulation.

批准信原文要点

This Prior Approval supplemental biologics application provides for a change to a new 150 mg/mL formulation and product presentation (pre-filled syringe with needle stick prevention) in S-009. The purpose of the supplemental BLA (sBLA) S-010 is to propose a new autoinjector product presentation using the 150 mg/mL formulation.

批准信原文要点

This Prior Approval supplemental biologics application provides for updates for the Clinical Trials section of the Prescribing Information (PI) and updates to the needle cover removal instructions (step 4) in the Instructions for Use (IFU).