Board Selected Drugs and any applicable information
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Board Selected Drugs from the May 20, 2024 PDAB Meeting are listed below.
Farxiga (dapagliflozin)
Drug Brand Name: Farxiga
Active Moiety or Active Ingredient: dapagliflozin
Application Number: NDA202293
Jardiance (empagliflozin)
Drug Brand Name: Jardiance
Active Moiety or Active Ingredient: empagliflozin
Application Number: NDA204629
Ozempic (semaglutide)
Drug Brand Name: Ozempic
Active Moiety or Active Ingredient: semaglutide
Application Number: NDA209637
Trulicity (dulaglutide)
Drug Brand Name: Trulicity
Active Moiety or Active Ingredient: dulaglutide
Application Number: BLA125469
Dupixent (dupilumab)
Drug Brand Name: Dupixent
Active Moiety or Active Ingredient: dupilumab
Application Number: BLA761055
Skyrizi (risankizumab)
Drug Brand Name: Skyrizi
Active Moiety or Active Ingredient: risankizumab
Application Number: BLA761105
Public written comment: Written public comments were due for the following Board Selected Drugs by close of business, Monday, July 22, 2024.
Comments Received (Packet)
- Abbvie
- Chase Brexton
- Ensuring Access Through Collaborative Health
- Lilly
- National Psorasis Foundation
- Novo Nordisk
- Value of Care Coaltion
Timeline Information for Cost Review:
- Public Comment period for all six drugs began on May 23, 2024. Comment period ends July 22, 2024.
- The Request for Information (RFI) for each drug in the Cost Review Study process will be posted on the website and the deadline will be based on when the RFI is posted. More information about the RFI Process will be posted on the website shortly.
- The Requests for Information (RFIs) for Farxiga (dapagliflozin), Jardiance (empagliflozin), Ozempic (semaglutide), Trulicity (dulaglutide) will be posted together, and the RFIs for Dupixent (dupilumab) Skyrizi (risankizumab) will be posted separately at a later date.