ALFALASTIN (human alpha-1 antitrypsin), proteinase inhibitor

Opinions on drugs - Posted on Jun 01 2017

Reason for request

Re-assessment of the actual benefit and the improvement in actual benefit

No clinical benefit demonstrated compared to usual treatment of emphysema in alpha-1 antitrypsin deficient patients.


  • ALFALASTIN has a Marketing Authorisation in replacement therapy for adults with severe forms of primary alpha-1 antitrypsin deficiency, phenotype PiZZ or PiSZ, with pulmonary emphysema.
  • The treatment is to be implemented as soon as possible after the first signs of emphysema. It is to be continued either continuously, especially in case of highly progressive emphysema, or through discontinuous cycles during episodes of bronchopulmonary infections.
  • The clinical relevance of the observed effect on the slowing of the loss of lung parenchymal density with ALFALASTIN compared to placebo cannot be estimated.



Clinical Benefit



Clinical Added Value

no clinical added value


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