Less than a year af­ter scor­ing a fast FDA OK for its pi­o­neer­ing acute myeloid leukemia drug gilter­i­tinib, Astel­las has snapped up a pos­i­tive rec­om­men­da­tion from Eu­ro­pean reg­u­la­tors fol­low­ing an ac­cel­er­at­ed as­sess­ment.

The CHMP thumbs up widens the gap be­tween Astel­las and Dai­ichi Sankyo, which has run in­to a road­block at the FDA when try­ing to field its own FLT3 tar­get­ed ther­a­py af­ter be­ing green-light­ed in Japan.

Dai­ichi’s drug, quizar­tinib, has al­so nabbed speedy re­view at the EMA.

Up to 30% of AML pa­tients have an FLT3 mu­ta­tion, which stim­u­lates the growth of ab­nor­mal leukemia cells. No­var­tis’ Ry­dapt is ap­proved on both sides of the At­lantic to treat the same group in com­bi­na­tion with chemother­a­py.

The mar­ket­ing au­tho­riza­tion for gilter­i­tinib — brand­ed Xospa­ta — will cov­er re­lapsed or re­frac­to­ry cas­es in adults.

So­cial im­age: Astel­las, AP Im­ages

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.