Respreeza (alpha1-proteinase inhibitor (human))
- Region
- 🇪🇺 EU
- Active substance
- alpha1-proteinase inhibitor (human)
- Company
- CSL Behring GmbH
- Status
- Authorised
- Therapeutic area
- Genetic Diseases, Inborn; Lung Diseases
- CHMP opinion
- Thu 25 Jun 2015
- EU approval
- Thu 20 Aug 2015
- Application
- EMEA/H/C/002739
- ATC
- B02AB02
- Official record
- www.ema.europa.eu
Indication
Respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null,null), PiSZ). Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
Regulatory milestones
Respreeza (human alpha1-proteinase inhibitor): DHPC sent to healthcare professionals
Quality defect; Genetic Diseases, Inborn, Lung Diseases · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.