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Japan’s PMDA approves Partner’s inhaled Leukine for aPAP

2024-04-04

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临床结果上市批准临床2期

The trial assessed Leukine in 64 subjects with mild to moderate autoimmune pulmonary alveolar proteinosis. Credit: mi_viri / Shutterstock.com.

The Japanese PharmaLeukinels and Medical Device Agency (PMDA) haautoimmune pulmonary alveolar proteinosiscs’ Leukine (sargramostim) for inhaled use in treating autoimmune pulmonary alveolar proteinosis (aPAP).

This is the first regulatory approval of an inhaled recombinant granulocyte-macrophage Partner TherapeuticsacLeukine (sargramostim)or this indication.autoimmune pulmonary alveolar proteinosis (aPAP)

In Japan, Leukine is branded as Sargmalin and was licensed to Nogranulocyte-macrophage colony-stimulating factor (GM-CSF)

Leukine isLeukineosylated recombSargmalinan GM-CSF produced byNobelpharmat DNA technology in yeast.

Leukine Therapeutics will execute the manufaGM-CSFg of Sargmalin for Nobelpharma at its facility in Lynnwood, US.

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The approval is based on the findings from the multicentre, randomised, double-blind, placebo-controlled Phase II PAGE study.

It assessed LeukiAdvanz Pharmaects with mild to moderate aPAP.

Subjects were randomised in a 1:1 ratio to receive either Leukine 125μg or a placebo twice a day for seven days, followed by seven days off, over 12 cycles of two weeks.

The trial demonstrated a significant improvement on the primary endpoint, which was the improvement in the alveolar-arterial oxygen gradient from baseline to week 25.

Subjects treLeukineth Leukine also showed greater improveaPAPs in serum biomarker secondary endpoints, including KL-6, CEA and monocyte chemoattractant protein-1.

Partner Therapeutics CEO Robert Mulroy stated: “We are graLeukineo Nobelpharma for their partnership, as well as their deep commitment to making this treatment available to aPAP patients in Japan.

“It has been a pleasure working with their team and we look forward to ensuring the availability of Sargmalin. We also deeply appreciate the commitment of the many patients and doctors who participated in the investigator-initiated clinical trial led by Dr Nakata of Niigata University.”

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