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news.The European Medicines Authority (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending Arch Biopartners' AB569 for designation as an orphan medicinal product to treat cystic fibrosis (CF).
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The orphan medicinal products designation is recommended for the two active ingredients of AB569, sodium nitrite and ethylenediaminetetraacetic acid (EDTA).
The positive opinion will now be forwarded to the European Commission (EC) for final approval of the orphan designation. The process is anticipated to be completed in the next few weeks.
Arch Biopartners chief science officer Daniel Muruve said: "The positive opinion by the COMP in favour of orphan medicinal status for the treatment of CF is indicative of the clinical need to combat antibiotic resistant airway infections often found in CF patients."
AB569 recently secured orphan drug designation from the US Food and Drug Administration (FDA) to treat antibiotic resistant Pseudomonas aeruginosa (P. aeruginosa) pulmonary infections in patients with CF.
Arch has recently arranged the manufacturing and toxicology program for AB569. The company intends to submit an investigational new drug application to the FDA in the second half of this year.
Cystic fibrosis patients are predisposed to lung infections because of abnormal mucus production in the lungs and airways.
The mean prevalence of cystic fibrosis is about 0.74 cases per 10,000 people among 27 European Union countries, which is below the defined limit for a rare or orphan disease.