Two years after its first FDA review, UCB’s next blockbuster Bimzelx finally crossed the finish line. Supplemental filings for more indications will soon follow as the company forecasts €4bn in peak sales.

While sales for the dual interleukin-17A and IL-17F inhibitor only reached €35m last year, UCB immunology chief Emmanuel Caeymaex is confident that figure will leap over the €200m barrier in 2023, if US approval for Bimzelx for psoriasis comes in the next quarter. 

Commissioner Robert Califf’s comments offer further context for FDA’s unprecedented decision to reconvene an advisory committee for a second review of Amylyx’ AMX0035 for ALS.

Attorneys say the biggest step FDA could take to expand access to medication abortion would be to eliminate REMS requirement for mifepristone. Timeline notes steps Biden administration and Congress have taken since the Supreme Court’s ruling overturning the right to an abortion.