A | B | C | |
---|---|---|---|
1 | Main | ||
2 | Brand | Trikafta | |
3 | Generic | elexacaftor, tezacaftor, ivacaftor | |
4 | Indication | 83,000 CF WW | |
5 | Regulatory | Expanded in children 6-11 years old 6/21 | |
6 | Reimbursed | 25 countries approved/reimbursed as of Q122. | |
7 | Canada | MA granted for 6-11yo | |
8 | Australia | signed reimbursement agreement with PBS | |
9 | EMA | 6-11yo label approved | |
10 | UK | 6-11yo label approved | |
11 | Clinical Trials | ||
12 | Phase III 2-5yo | ||
13 | sNDA by YE22 |