Arch Biopartners, Inc, announced that it recently submitted an orphan drug designation application to the European Medicines Authority (EMA) for its product AB569, a potential treatment of pulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis (CF).
The EMA is now reviewing the application, and the Committee for Orphan Medicinal Products (COMP) is expected to initiate a formal assessment process in about a month’s time. COMP will forward an opinion on the application’s merits to the European Commission (EC), likely by the end of May. Depending on the recommendations, the EC will then decide whether to grant an orphan drug designation for AB569, a press release stated.
Pseudomonas aeruginosa is a common bacteria found in soil, water, skin flor, and other man-made environments, where it thrives with and without the presence of oxygen. Infection with P. aeruginosa causes generalized inflammation, and the bacteria may colonize critical body organs like the lungs, kidneys, and urinary tract. P. aeruginosa is a significant cause of bacterial respiratory infections in patients who have CF or chronic obstructive pulmonary disease (COPD). It is also a common cause of pneumonia.
A number of antibiotics are currently available to treat P. aeruginosa infections, including aminoglycosides, quinolones, and carbapenems. However, P. aeruginosa has an extreme potential for developing resistance to antibiotics and other phagocyte-mediated killing strategies.
Arch Biopartners’ AB569 is a novel therapy for pulmonary infections with mucoid and non-mucoid P. aeruginosa bacteria that are resistant to traditional antibiotics. AB569 received orphan drug designation from the U.S. Food and Drug Administration (FDA) in November 2015 for its combined active ingredients in an inhaled solution. The drug, which was developed at the University of Cincinnati in Dr. Daniel Hassett’s laboratory, combines two active ingredients, sodium nitrite and ethylenediaminetetraacetic acid.
The EMA plays a central role in the development and authorization of medicines for rare diseases in Europe. Orphan drug designation allows a pharmaceutical company to benefit from EU incentives to develop treatments for rare diseases, such as reduced fees and protection from competition once the medicine is placed on the market.