The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for Respreeza, a highly purified alpha-1 protein derived from human plasma, indicated to treat patients with alpha-1 antitrypsin deficiency (AATD).
Respreeza, which is manufactured by CSL Behring, replaces the protein that these patients are missing and raises the alpha-1 antitrypsin levels in their blood, which can help to protect the lungs from damage due to inflammation.
The CHMP positive opinion will be transmitted to the European Commission (EC) to start the EC decision-making process. The EC may then grant a marketing authorization for Respreeza as a maintenance treatment to slow the progression of emphysema in adults with documented severe alpha-1 proteinase inhibitor deficiency.
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