A defective INR device used to monitor blood clotting in the main study supporting the 2011 approval of Bayer AG's new oral anticoagulant Xarelto (rivaroxaban) in stroke prevention in atrial fibrillation had no effect on the safety and benefit/risk balance of the product, the EMA has concluded. Xarelto can continue to be used as before, in line with the current prescribing information, it said.
Bayer's Xarelto 'Safe' Despite ROCKET Device Defect
A defective INR device used to monitor blood clotting in the main study supporting the 2011 approval of Bayer AG's new oral anticoagulant Xarelto (rivaroxaban) in stroke prevention in atrial fibrillation had no effect on the safety and benefit/risk balance of the product, the EMA has concluded. Xarelto can continue to be used as before, in line with the current prescribing information, it said.
More from Cardiovascular
More from Therapy Areas
The pact could be worth more than $2.6bn and adds to growing big pharma investment in the technology.
Following the near-total dominance of IgG antibodies, the UK group is backing the potential of IgA and IgE-based therapies to transform cancer treatment with the purchase of US-headquartered TigaTx.
By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.