Infectious Disease

Paratek receives orphan drug status for Nuzyra for the treatment of NTM lung disease

August 20, 2021

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Brenner is employed by Paratek Pharmaceuticals.

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The FDA has given Paratek Pharmaceuticals orphan drug status to Nuzyra for the treatment of infections caused by nontuberculous mycobacteria, the company announced this week.

Nuzyra (omadacycline) – a once-daily broad spectrum antibiotic – has already been approved by the FDA for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.

FDA approval

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Orphan drug status, which includes non-tuberculous mycobacteria (NTM) caused by the Mycobacterium abscessus complex, “is an important regulatory milestone in our efforts to investigate the utility of Nuzyra as a potential therapeutic option for patients with M. further confirms abscess lung disease, a rare disease for which there are no approved therapies, ”said Paratek Chief Development and Regulatory Officer Randy BrenneR., MRS, said in a press release.

“Earlier this year, we began our phase 2b clinical trial to evaluate the efficacy and safety of Nuzyra in patients with M. abscessus lung disease,” said Brenner. “These clinical data will continue to build on the growing data and publications on Nuzyra and its potential benefits in NTM abscess.”

According to Paratek, around 11,500 patients in the United States are affected by M. abscessus infections. Standard treatment includes several antibiotics, most of which are given intravenously, which can often require lifelong treatment made difficult by long-term tolerability issues and several side effects, Paratek said.

References:

Clinical trials. Oral omadacycline. https://www.clinicaltrials.gov/ct2/show/NCT04922554?lead=paratek&draw=2&rank=1. Retrieved on August 19, 2021.

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