Published on Tuesday, March 29, 2016
Kamada has submitted a Marketing Authorization Application with the European Medicines Agency (EMA), seeking permission to market its inhaled therapy for Alpha-1 Antitrypsin Deficiency in Europe.
The EMA, the European equivalent of the U.S. Food and Drug Administration (FDA), will now consider whether to allow Kamada to market the product, a version of augmentation therapy that is taken by aerosol through a nebulizer twice a day.
“This application raises the exciting possibility that an alternative augmentation therapy may become available to Alphas in Europe. However, I would caution that an application is not the same as receiving approval for a new therapy,” said Robert “Sandy” Sandhaus, clinical director of the Alpha-1 Foundation and medical director of AlphaNet.
A Marketing Authorization Application (MAA) is an application by a drug manufacturer seeking permission to bring a new drug to market. The MAA is part of the official procedure in Europe and the United Kingdom to win approval for marketing a new drug. The MAA is equivalent to a New Drug Application made to the Food and Drug Administration (FDA) in the United States.
Jan Stolk, MD, of the Department of Pulmonology, Leiden University, was the principal investigator of the clinical trial that led to the application. “The submission of the MAA for inhaled alpha-1 antitrypsin to treat AATD is a major step toward bringing another treatment to AATD patients,” Stolk said. “This study is the first study ever that shows inhaled AAT’s ability to reduce the decline in FEV1 in a patient population suffering from frequent exacerbations of dyspnea and coughing.”
A study of the same inhaled drug therapy was recently completed at two centers in the United States, the University of Florida and the University of Texas at Tyler, in preparation for an eventual application to the FDA for approval in the United States.
To read Kamada’s press release about the application, click here.