Novel Antibiotic Formulation For Treating Acinetobacter Infections in CF Receives New Drug Application Approval From FDA

Novel Antibiotic Formulation For Treating Acinetobacter Infections in CF Receives New Drug Application Approval From FDA

The Medicines Company recently announced in a news release that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental new drug application (sNDA) for a new injectable formulation of the antibiotic MINOCIN® (minocycline). The news is significant for the cystic fibrosis community, as MINOCIN is used to treat Acinetobacter infections, which are both prevalent and potentially life-threatening for CF patients.

MINOCIN is a broad-spectrum tetracycline antibiotic and its formulation for injection has been approved for the treatment of infections by susceptible gram-positive and gram-negative bacteria, such as infections associated to Acinetobacter species. The Centers for Disease Control and Prevention (CDC) considers the multi-drug resistant Acinetobacter a serious threat that typically occurs in patients who are hospitalized. It is estimated that the Acinetobacter species may be responsible for up to 80,000 infections every year in the United States and one million infections throughout the world.

“We believe the new formulation of MINOCIN for Injection will offer clinicians an improved IV [intravenous] formulation that may allow for easier administration by using a lower fluid volume in patients with serious infections, including those caused by Acinetobacter spp.,” said the Senior Vice President and Head of Global Health Science, Infectious Disease Global Innovation Group, The Medicines Company, Dr. Michael Dudley in a news release.

“Clinicians, regulators, and public health authorities have increasingly recognized the threat of multi-drug resistant bacteria to our healthcare system,” said the Fellow of the College of Chest Physicians (FCCP) Infectious Disease Specialist Dr. Debra Goff. “MINOCIN for injection is an example of stewardship efforts to identify drugs to meet the challenge of infections in the hospital. Patients and clinicians have very limited choices, and thus having FDA-approved drugs for treatment of infections due to Acinetobacter spp. will be important for their treatment.”

The new MINOCIN for Injection formulation was also granted by the FDA the Qualified Infectious Disease Product (QIDP) designation, which qualifies it for priority review and five years of marketing exclusivity once the additional potential indications are approved. “We are also pleased that FDA has recognized the potential value MINOCIN for Injection can bring to patients with difficult-to-treat infections due to serious pathogens by granting QIDP designation,” added Dr. Dudley.

The new potential indications for MINOCIN involve gram-negative bacteria and include: 1) treatment of ventilator-associated bacterial pneumonia (VABP) and hospital-acquired bacterial pneumonia (HABP), 2) treatment of pulmonary infections by Burkholderia cepacia complex in patients with chronic granulomatous disease, a genetic disorder characterized by chronic severe infections and dysfunction in certain cells of the immune system, and finally 3) treatment of pulmonary infections and exacerbations due to Burkholderia cepacia complex or Stenotrophomonas maltophilia bacteria in patients with cystic fibrosis, a life-threatening genetic disease in which a defective gene causes the body to form unusually thick, sticky mucus that can result in serious respiratory and gastrointestinal manifestations.

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