Company

Product

Description

Indication

Status

Canbridge Pharmaceuticals Inc., of Beijing and Shanghai

Hunterase (idursulfate beta)

Human recombinant iduronate-2-sulfatase enzyme replacement therapy

Hunter syndrome (mucopolysaccharidosis type II)

China's National Medical Products Administration granted priority review for the recently submitted NDA

Intra-Cellular Therapies Inc., of New York

Lumateperone

Modulates serotonin, dopamine and glutamate

Schizophrenia

FDA informed the firm it does not plan to schedule an advisory committee in connection with its review of NDA; PDUFA date is Dec. 27, 2019

Ultragenyx Pharmaceutical Inc., of Novato, Calif., and Kyowa Kirin Co. Ltd., of Tokyo

Crysvita (burosumab)

Recombinant fully human monoclonal IgG1 antibody against FGF23

FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors (tumor-induced osteomalacia)

Following pre-sBLA meeting with FDA, disclosed plans to submit supplemental BLA for use in tumors that cannot be curatively resected or localized; submissions expected in first half of 2020

Xeris Pharmaceuticals Inc., of Chicago

Gvoke (glucagon)

Ready-to-use, room-temperature stable liquid glucagon

Severe hypoglycemia

Approved by FDA for use in pediatric and adult patients with diabetes, ages 2 and older


Notes

For more information about individual companies and/or products, see Cortellis.

 

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