AstraZeneca's Priority Review good news provides reprieve

This latest piece of good news for AZ comes after the same drug received a breakthrough designation just yesterday based on Phase 2 data for the treatment of mantle cell lymphoma, a type of blood cancer. The Priority Review means that the FDA will review AZ’s application within six months, as opposed to 10 months under standard review. This was added to the news that Imfinzi had also received breakthrough designation.

Dependent upon how this process pans out, it could see AZ enter 2018 with an approval of a drug slated for blockbuster status. It will be pinning a lot of hope on this being the case, after shelling out $4 billion to buy a majority stake in Acerta – the company that created the candidate.

The drug is a selective, covalent inhibitor of Bruton tyrosine kinase inhibitor that is being developed for the treatment of multiple B-cell and other cancers. Should it be approved, it would enter the market as a competitor to Imbruvica, the BTK inhibitor from J&J and AbbVie. There are already suggestions that the drug could prove to be more effective than its competitor, providing AZ’s with some punch after it had seemed gassed out after the Mystic blow.

Imbruvica managed sales of $2.2 billion last year, across its indications, and analysts point towards peak annual sales of around $1 billion for acalabrutinib. AZ CEO, Soriot, had pitched the drug as capable of $5 billion in annual sales but this figure now seems unlikely.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: "FDA’s acceptance of the acalabrutinib application and Priority Review illustrates the impact it could have on patients with relapsed or refractory mantle cell lymphoma as we work to bring this potential medicine to those in need as quickly as possible."