Evicenter
P&T meetings

Molgramostim Inhalation Solution

Autoimmune pulmonary alveolar proteinosis

Manufacturer
Savara
Regulatory submission
BLA resubmitted December 2025
Launch
Not announced
89 sources

Section 1 of 6

Terms and abbreviations

1 evidence topic · 0 sources

AbbreviationTerm
A-aDO2Alveolar-arterial oxygen difference
AHFSAmerican Hospital Formulary Service
aPAPAutoimmune pulmonary alveolar proteinosis
ATCAnatomical Therapeutic Chemical classification
ATSAmerican Thoracic Society
BLABiologics License Application
CIConfidence interval
COVID-19Coronavirus disease 2019
CYFRA21-1Cytokeratin 19 fragment
DBSCDried blood spot card
DLCODiffusing capacity of the lungs for carbon monoxide
DLCOadjDiffusing capacity of the lungs for carbon monoxide adjusted for hemoglobin
ECExercise capacity
EMAEuropean Medicines Agency
EQ-5D-5LEuroQol 5 Dimensions, 5 Levels
ERSEuropean Respiratory Society
ETDEstimated treatment difference
FASFull analysis set
FDAU.S. Food and Drug Administration
GM-CSFGranulocyte-macrophage colony-stimulating factor
GMAbGM-CSF autoantibody
HRQoLHealth-related quality of life
IMPInvestigational medicinal product
KL-6Krebs von den Lungen-6
LDHLactate dehydrogenase
LSMLeast-squares mean
MAAMarketing Authorisation Application
MADMultiple ascending dose
MDMean difference
METMetabolic equivalent
MHRAMedicines and Healthcare products Regulatory Agency
MOL-MOLMolgramostim during both double-blind and open-label treatment
NSNot significant
PAPPulmonary alveolar proteinosis
PBOPlacebo
PDPharmacodynamics
PDUFAPrescription Drug User Fee Act
PKPharmacokinetics
PROPatient-reported outcome
RTFRefusal to File
SADSingle ascending dose
SGRQSt. George’s Respiratory Questionnaire
SGRQ-ASt. George’s Respiratory Questionnaire Activity score
WBCWhite blood cell
WLLWhole lung lavage