Latest Japan Approvals Include World-First For Pabinafusp

Other Nods For Vitrakvi, Polivy

25 Mar 2021

A new batch of marketing authorizations in Japan includes new therapies for high-need cancer indications and rare diseases, and the first nod worldwide for a novel lysosomal disorder treatment that can address serious CNS symptoms.

Japan MHLW — Japan Ministry Approves Multiple New Drugs, Including A World-First • Source: Shutterstock

JCR Pharmaceuticals Co., Ltd. has received the first approval worldwide, in Japan, for Izcargo (pabinafusp alfa), its novel therapy for mucopolysaccharidosis type II (MPS II, or Hunter syndrome).

The drug, formerly known as JR-141, was filed last September and is a recombinant fusion protein of an antibody against...