Lilly’s Sarcoma Drug Lartruvo Latest To Test EU Conditional Approval System
Lartruvo, Lilly’s new drug for the rare condition soft tissue sarcoma, has been recommended for conditional marketing authorization in the EU pending the results of an ongoing Phase III study. The conditional approval system itself is under scrutiny regarding the fulfilment of obligations.
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The promise seen in Lartruvo, Lilly’s new drug for the rare condition soft tissue sarcoma, should offset payer and HTA reluctance to use the monoclonal antibody despite its conditional EU marketing approval status.
Accelerated filing was supported by trial of patients with 25 subtypes of soft tissue sarcoma and confirmatory study will span 50 kinds.
The European Commission is to conduct an analysis of the impact of incentives such as data exclusivity, market exclusivity and patent term extensions on innovation, drug pricing, and access to medicines, including generics. The move was requested by member state health ministers who say they are concerned about cases of 'very high and unsustainable price levels' hindering patient access to effective and affordable medicines.