Two years af­ter scrap­ping three he­mo­phil­ia tri­als, No­vo Nordisk plots route to FDA with new PhI­II da­ta

No­vo Nordisk con­tin­ues to move for­ward with its once-dai­ly mon­o­clon­al an­ti­body for he­mo­phil­ia A or B treat­ment aim­ing to stop ex­ces­sive bleed­ing events be­fore they hap­pen, tout­ing new Phase III da­ta Sun­day.

The Dan­ish phar­ma put out word that a piv­otal tri­al for con­cizum­ab achieved its pri­ma­ry goal, re­duc­ing spon­ta­neous and trau­mat­ic bleeds by 86% in a pro­phy­lac­tic set­ting com­pared to a con­trol arm. No­vo Nordisk is de­vel­op­ing the can­di­date such that he­mo­phil­ia A or B pa­tients can take it re­gard­less of whether they de­vel­op im­mune re­spons­es to oth­er drugs.

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