Drug Development

Your attention, please: AstraZeneca asks for a moment of rapt silence, for a BLA acceptance?

AstraZeneca $AZN made an odd move this morning for a Big Pharma company. It halted trading in its shares to announce that the FDA has accepted its BLA for marketing its PD-L1 checkpoint inhibitor durvalumab against bladder cancer. That’s a small biotech kind of move aimed at gaining everyone’s attention, but it’s understandable in AstraZeneca’s case.

The acceptance comes just days after the Pfizer/Merck KGaA team beat them to the punch with a rival checkpoint, avelumab. AstraZeneca has been falling behind a lineup of competitors who are already on the market, so getting beat by the Pfizer/Merck KGaA team must have stung considerably.

Like its rivals, AstraZeneca is also getting a priority review, leaving a formal decision for Q2, when we’ll likely see two more checkpoints join Bristol-Myers Squibb’s Opdivo, Merck’s Keytruda and Roche’s Tecentriq.

Durvalumab has emerged as the single most important program in the AstraZeneca pipeline. But as the other competitors surged to the front, AstraZeneca opted to switch gears to focus on combo drugs. Gaining a major market entry with this drug is absolutely critical to Pascal Soriot’s plans for growing revenue as generic competition sinks its teeth into lead products.

And these days, with more bad news than good in the headlines, AstraZeneca will take whatever it can get.


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RAPS Regulatory Convergence 2017