Shots:
- Following the US FDA approval, EMA’s CHMP issued a positive opinion of Brukinsa (zanubrutinib) film‑coated tablets for all approved indications. EC will now review the opinion for MAA in the EU, Norway, and Iceland
- BRUKINSA tablets (160mg) are bioequivalent to the capsule form, supported by a P-I study. With a recommended daily dose of 320mg, the new tablet will reduce the dose frequency to two tabs/day and will maintain dosing flexibility, allowing QD/BID administration and easier dose adjustments
- Tablets will replace capsules globally from 2025 (ex‑China), reducing bottle size by ~70%, lowering temperature control needs; the tablet formulation is already approved in the U.S.
Ref: Business Wire| Image: Beone | Press Release
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