AstraZeneca earmarks cancer drugs for early access to medicines scheme - fast tracking orphan drugs briefing

AstraZeneca Eyes Early Access Schemes for Cancer Drugs

In Market Access, Regulation & Government by Yolanda King

AstraZeneca’s two new cancer drugs, known as AZD9291 and MEDI4736 have both been marked as possible medicines for early access schemes, both in the UK and throughout the world.

Early access schemes aim to get innovative medicines to patients quicker and are usually for medicines in an area of unmet need. Britain’s Early Access to Medicines Scheme, which is only a few months old has been suggested as a possible scheme that Pascal Soriot, Chief Executive of AstraZeneca is considering for the two medicines, as reported in The TelegraphAlongside this, there are early access schemes operating in the US, France and Japan which could provide other avenues for AstraZeneca to explore, to speed up the new drugs access to patients. AZD9291 has in fact already received ‘breakthrough status’ by the US regulator, meaning that it will now be fast-tracked through the regulatory process, setting a positive benchmark for other countries to follow.

AZD9291 and MEDI4736 were both at the heart of AstraZeneca’s defense against Pfizer’s takeover approach, with MEDI4736 forecast to generate peak annual sales of up to $6.5bn, as reported in the Financial Times. These two drugs are therefore key to maintaining AstraZeneca’s independence, in order to stop a decline in revenues as older drugs lose their patent protection.

If you are interested in learning more about the UK’s Early Access to Medicines Scheme, along with the EMA’s Adaptive Licensing pilot program, which aims to fast track drugs as well, why not join us for the inaugural Fast Tracking Orphan Drugs Briefing on 10th July in London. Join industry experts from Alexion, Shire, Clinigen and Trophos to discuss how companies can move forward in this innovative landscape. Download the brochure here.

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