EMA Deciding If Donanemab For Alzheimer’s & Three Other Drugs Merit Fast-Tracking

Eli Lilly, MSD, CLS and Pfizer could this week find out if the European Medicines Agency will agree that their planned EU marketing applications for donanemab, sotatercept, garadacimab and aztreonam-avibactam respectively deserve an accelerated assessment.

Alzheimer's puzzle
Lilly's donanemab is designed to slow Alzheimer’s disease progression • Source: Shutterstock

The European Medicines Agency was this week due to consider requests from four companies that want it to fast-track its reviews of their planned EU drug marketing authorization applications (MAAs), including one from Eli Lilly for its Alzheimer’s disease drug candidate, donanemab.

More from Europe

EU Critical Medicines Act Unveiling On 11 March–Industry Backs, But Urges Caution

 

The new act aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU. It should recognize differences between generics and innovative products, says industry group EUCOPE.

UK: New ILAP Will Involve Discussions On ‘Commercial Flexibilities’ For Innovative Products

 

The UK drug regulator has made a number of improvements to its innovative licensing and access pathway, including a more “core” role for National Health Service partners, which is expected to facilitate flexible commercial discussions around drug reimbursement.

Third Time Lucky? Eli Lilly and Eisai Get Another Shot At English Funding For Alzheimer’s Drugs

 

Cost and evidence gaps remain barriers for Kisunla and Leqembi as NICE rejects the drugs again but opens further consultations on the reimbursement of the Alzheimer's disease-modifying treatments.

EU Explains New Health Data Space Rules As Framework Becomes ‘A Reality’

 

The European Commission has confirmed that pharmaceutical companies will be able to request access to data for research under the new European Health Data Space Regulation, which has been published in the EU Official Journal and will enter into force on 26 March.

More from Geography

EU Critical Medicines Act Unveiling On 11 March–Industry Backs, But Urges Caution

 

The new act aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU. It should recognize differences between generics and innovative products, says industry group EUCOPE.

UK: New ILAP Will Involve Discussions On ‘Commercial Flexibilities’ For Innovative Products

 

The UK drug regulator has made a number of improvements to its innovative licensing and access pathway, including a more “core” role for National Health Service partners, which is expected to facilitate flexible commercial discussions around drug reimbursement.

Global Pharma Guidance Tracker – February 2025

 

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.