FDA Approves Paratek's Nuzyra

Wednesday, October 03, 2018 | FDA Approval/Clearance , Product Launches and Updates


The FDA has approved Paratek Pharmaceuticals, Inc's Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). Nuzyra, a modernized tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug resistant strains. The company plans on making Nuzyra available in the first quarter 2019.

“In the face of ever-increasing antibiotic resistance, the FDA approved Nuzyra with a label having full approval for both CABP and ABSSSI.  We are excited to bring to physicians an effective, well-tolerated monotherapy option for patients,” said Evan Loh, MD, President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Nuzyra offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalizations and the costs associated with hospital stays.”

The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States. The main bacteria causing CABP, Streptococcus pneumoniae, is responsible for 1.2 million infections and 7,000 deaths, whereas ABSSSI is responsible for more than 750,000 hospitalizations. The increase of antibiotic resistance continues to drive the need for new, effective therapies. 

“Treating pneumonia and skin infections has become increasingly complex as existing antibiotic therapies sometimes have reduced efficacy as resistance continues to grow. This reality makes it increasingly challenging to provide safe and effective treatments to patients,” said Keith Kaye, MD, MPH, Director of Clinical Research, Division of Infectious Diseases, University of Michigan. “There continues to be a need for novel antibiotics with both IV and oral formulations, such as Nuzyra, to help physicians stay ahead of the evolving resistance landscape.”

The approval of Nuzyra is supported by multiple clinical trials within the company’s global development program. Nearly 2,000 adult patients received Nuzyra and it was found to be efficacious and generally safe and well tolerated.  As part of the approval, Paratek has agreed to conduct post marketing studies in CABP and pediatrics.

“The approval of Nuzyra is an historic milestone for Paratek as it represents 20 years of research and development of this life-saving antibiotic for patients affected by community-acquired infections,” said Michael F. Bigham, Chairman and CEO, Paratek. “There are countless champions of Nuzyra who have been tireless in their efforts to ensure its advancement to commercialization – from patients, clinicians and study investigators to our Paratek team. We are grateful to all who played a role in making Nuzyra available to patients in need. We are excited to launch Nuzyra early next year.”

Next Story

Comments

You must be logged in to leave a comment.