Go or no go? The FDA plays hardball

Pfizer’s abrocitinib is forecast to become an important new growth driver for the company, but it needs to get to market first. Next month the US FDA is set to rule on approval in the project's first indication, atopic dermatitis, and the decision will be made amid close scrutiny of the safety of the Jak inhibitor class.

The agency will also take on accelerated approvals in a panel meeting that will discuss whether six anti-PD-(L)1s, from Roche, Merck & Co and Bristol Myers Squibb, should remain conditionally available. Elsewhere, Takeda hopes to get the green light in a rare inflammatory disease where the competition is not far behind.