Germany’s IQWiG Approves Eliquis For AF, But Restricts Its Indication
This article was originally published in The Pink Sheet Daily
Germany’s HTA IQWiG has approved Bristol/Pfizer’s Eliquis (apixaban) for atrial fibrillation but restricted the oral anticoagulant’s indication, leaving a potential gap for its rivals to fill.
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Bristol and Pfizer expect to launch novel anticoagulant Eliquis within weeks in Germany and the U.K. following approval in Europe on Nov. 20. Eliquis looks well-positioned to compete in Europe with a label reflecting superiority on safety, efficacy for stroke prevention and mortality.
MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.
The EMA has recommended suspension of some 700 drug formations linked with Indian clinical trials company GVK Biosciences, but assures national agencies that this won’t result in shortages or safety issues.