PARSIPPANY, NJ, USA I February 27, 2014 I The Medicines Company (NASDAQ: MDCO) today announced that the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for the investigational intravenous antibiotic, oritavancin, for the treatment of complicated skin and skin tissue infections (cSSTI), caused by susceptible gram-positive bacteria, including by methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose.
The oritavancin MAA is based on data from two Phase 3 clinical trials, SOLO I and SOLO II. These Phase 3 trials evaluated the efficacy and safety of a single 1200 mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with cSSTI, including infections caused by MRSA. cSSTI are also known as acute bacterial skin and skin structure infections (ABSSSI). The combined SOLO studies were conducted in 1,959 patients (modified intent-to-treat population, or mITT), with 405 of the patients suffering from a cSSTI with a documented MRSA infection.
The acceptance of the MAA marks the beginning of the review process in the European Union for oritavancin. Oritavancin is also under review by the US Food and Drug Administration (FDA) in the United States.
About Oritavancin
Oritavancin is an investigational intravenous antibiotic for which The Medicines Company is seeking approval for the treatment of cSSTI (known as acute bacterial skin and skin structure infections (ABSSSIs) in the US) caused by susceptible gram-positive bacteria, including MRSA. In clinical trials, the most frequently reported adverse events associated with oritavancin were nausea, headache, vomiting and diarrhea. Hypersensitivity reactions have been reported with the use of antibacterial agents, including oritavancin.
About The Medicines Company
The Medicines Company’s purpose is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on 3,000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
SOURCE: The Medicines Company
Post Views: 103
PARSIPPANY, NJ, USA I February 27, 2014 I The Medicines Company (NASDAQ: MDCO) today announced that the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for the investigational intravenous antibiotic, oritavancin, for the treatment of complicated skin and skin tissue infections (cSSTI), caused by susceptible gram-positive bacteria, including by methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose.
The oritavancin MAA is based on data from two Phase 3 clinical trials, SOLO I and SOLO II. These Phase 3 trials evaluated the efficacy and safety of a single 1200 mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with cSSTI, including infections caused by MRSA. cSSTI are also known as acute bacterial skin and skin structure infections (ABSSSI). The combined SOLO studies were conducted in 1,959 patients (modified intent-to-treat population, or mITT), with 405 of the patients suffering from a cSSTI with a documented MRSA infection.
The acceptance of the MAA marks the beginning of the review process in the European Union for oritavancin. Oritavancin is also under review by the US Food and Drug Administration (FDA) in the United States.
About Oritavancin
Oritavancin is an investigational intravenous antibiotic for which The Medicines Company is seeking approval for the treatment of cSSTI (known as acute bacterial skin and skin structure infections (ABSSSIs) in the US) caused by susceptible gram-positive bacteria, including MRSA. In clinical trials, the most frequently reported adverse events associated with oritavancin were nausea, headache, vomiting and diarrhea. Hypersensitivity reactions have been reported with the use of antibacterial agents, including oritavancin.
About The Medicines Company
The Medicines Company’s purpose is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on 3,000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
SOURCE: The Medicines Company
Post Views: 103
