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Avastin Can Be Used Off Label For AMD, Says UK MHRA

 
• By Ian Schofield

The UK regulator has clarified its guidance on the use of the anticancer Avastin for age-related macular degeneration, saying that reformulating the drug into small vials for ophthalmic injection represents an off-label use of the Roche product and does not create an unlicensed medicine.

Human eye
The MHRA has changed its guidance on the use of Avastin in the eye

The UK regulatory agency, the MHRA, has changed its advice on the use of Roche’s Avastin (bevacizumab) in the unapproved indication of age-related macular degeneration (AMD) at the request of the High Court, which last year rejected attempts by Novartis and Bayer to stop Avastin being used for the degenerative eye condition in the UK.

The agency now says that if a health professional prescribes or uses Avastin for AMD after it has been compounded for intravitreal injection, this falls under the scope of “off-label...

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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.