Shots:

• The EC has granted marketing authorization to Kapruvia for the treatment of mod. to sev. pruritus associated with CKD in hemodialysis patients. The therapy is expected to launch in the EU in H2’22
• The approval was based on the 2 P-III trials i.e., (KALM-1 & 2) along with supportive data from an additional 32 clinical studies of Kapruvia which showed improvements in pruritus severity & pruritus-related QoL components. The therapy was found to be well tolerated in patients with CKD-associated pruritus
• The approval will be valid in all member states of the EU, Iceland, Liechtenstein & Norway, based on the US FDA’s approval of Korsuva (difelikefalin) in August 2021 for the same indication

Ref: Businesswire | Image: Cara