Clinical Paratek gets FDA's orphan drug designation for NUZYRA for...

Paratek gets FDA’s orphan drug designation for NUZYRA for treating infections caused by Nontuberculous Mycobacteria

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The U.S. Food and Drug Administration (FDA), on August 18, 2021, has granted Paratek Pharmaceuticals’ drug, NUZYRA® (omadacycline), an orphan drug designation for the treatment of Nontuberculous Mycobacteria (NTM) related infections.

The U.S. based biopharmaceutical company aims at developing and commercializing medicines for community-acquired life threatening bacterial infections or diseases. 

With no FDA-approved antibiotic therapies, NTM-caused pulmonary infections affect roughly 11,500 patients throughout the United States. Currently, Paratek is conducting phase II-b trials targeting NTM pulmonary disease caused by Mycobacterium Abscessus Complex (MABc) for which the orphan drug designation has been granted.

The study conducted in phase II-b trials is for the randomized monotherapy of the said drug in patients who are in the initial phase of treatment and do not have received any other antibiotic treatments yet. The company expects to take about two years to complete the enrollment due to a limited number of patients. 

The drugs or biologics are given the status of orphan by the FDA’s Office of Orphan Drug Products, upon ensuring promising results for the treatment of diseases or conditions that affect less than 200,000 people.  

Upon approval, an orphan drug designation helps provide certain development incentives and benefits to the company, such as exemptions from certain FDA application fees, tax credits for qualified clinical testing and potential market exclusivity. Randy Brenner, Chief Development and Regulatory Officer of Paratek Pharmaceuticals, stated, “The orphan drug designation is an important regulatory milestone that further validates our efforts to investigate the utility of NUZYRA, a once-daily, broad-spectrum antibiotic currently approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, as a potential therapy option for patients afflicted with M.abscessus pulmonary disease, an orphan disease for which there are no approved therapies.”

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