Paratek receives orphan drug status for Nuzyra to treat NTM lung disease
The FDA granted Paratek Pharmaceuticals orphan drug designation for Nuzyra to treat infections caused by nontuberculous mycobacteria, the company announced this week.
Nuzyra (omadacycline) — a once-daily, broad-spectrum antibiotic — is already FDA-approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.
The orphan drug designation, which includes nontuberculous mycobacteria (NTM) pulmonary disease caused by Mycobacterium abscessus complex, “is an important regulatory milestone that further validates our efforts to investigate the utility of Nuzyra ... as a potential therapy option for patients afflicted with M. abscessus pulmonary disease, an orphan disease for which there are no approved therapies,” Paratek Chief Development and Regulatory Officer Randy Brenner, MS, said in a news release.
“Earlier this year, we initiated our phase 2b clinical study that is designed to examine the efficacy and safety of Nuzyra in patients with M. abscessus pulmonary disease,” Brenner said. “These clinical data will continue to build upon the expanding data and publications about Nuzyra and its potential utility in NTM abscessus.”
According to Paratek, infections caused by M. abscessus affect approximately 11,500 patients in the United States. Standard treatment involves multiple antibiotics, mostly administered intravenously, which can often require a life-long treatment, complicated by long-term tolerability challenges and multiple adverse events, Paratek said.
References:
Clinical Trials. Oral omadacycline. https://www.clinicaltrials.gov/ct2/show/NCT04922554?lead=paratek&draw=2&rank=1. Accessed August 19, 2021.
Collapse
Press Release.
Read more about