Injection-Based MINOCIN For Treating Acinetobacter in CF Gets FDA New Drug Application Approval

Injection-Based MINOCIN For Treating Acinetobacter in CF Gets FDA New Drug Application Approval

The Medicines Company recently announced that it has received approval by the United States Food and Drug Administration (FDA) concerning the supplemental new drug application (sNDA) for MINOCIN® (minocycline) for Injection, a new formulation to address infections in cystic fibrosis patients.

Additionally, the FDA has also granted the Qualified Infectious Disease Product (QIDP) designation for MINOCIN under the Generating Antibiotic Incentives Now Act (GAIN Act). This designation, if granted, would be the third given to a product of the company’s portfolio for infectious disease and would put MINOCIN in the priority group to be reviewed and 5 years of marketing exclusivity.

MINOCIN for Injection derives from a tetracycline approved in the United States and it is suitable to treat infections caused by Acinetobacter species that typically affect hospitalized patients as well as those with cystic fibrosis. Resistance to Acinetobacter is considered to be a serious threat by the United States Centers for Disease Control and Prevention (CDC). The CDC estimates there might be up to 80,000 infections caused by Acinetobacter species each year in the US, and about 1 million in the world.

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

Dr. Debra Goff from the FCCP Infectious Disease Specialist, The Ohio State University Wexner Medical Center concluded: “Clinicians, regulators, and public health authorities have increasingly recognized the threat of multi-drug resistant bacteria to our healthcare system. 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.”

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