COPENHAGEN, Denmark & BUFFALO GROVE, IL.--(BUSINESS WIRE)--Xellia Pharmaceuticals (‘Xellia’), a global leader in the manufacturing of specialty anti-infective treatments, announced today it has received U.S. Food and Drug Administration (FDA) approval for Premixed Vancomycin Injection in a Ready-to-Use (RTU) bag in the United States market. This approval follows Qualified Infectious Disease Product (QIDP) designation from the FDA in February 2018.
“In 2014 we started on a journey to develop a pipeline of innovative, novel anti-infective therapies focused on unmet medical needs and centered on advanced formulation improvements for marketed drugs from our core portfolio. This first approval is a significant milestone for Xellia and an important validation of our strategy,” said Carl-Åke Carlsson, Xellia’s CEO.
“It is a testament to our science, formulation and medical expertise that enabled us to successfully overcome the long standing industry challenge of stabilizing Vancomycin in solution at room temperature for an extended time, 16 months. We are continuing innovative R&D efforts with the goal to further broaden our portfolio of novel anti-infective therapies aimed at enhancing patient care and improving convenience and ease of use for healthcare professionals.” said Dr. Aleksandar Danilovski, Xellia's CSO.
Craig Boyd, Xellia’s North American President said, “Vancomycin is a critical World Health Organization (WHO) designated essential medicine. With this approval, US healthcare professionals will now have access to multiple presentations (500 mg in 100 mL, 1 g in 200 mL, 1.5 g in 300 mL and 2 g in 400 mL) of the first room temperature stable Vancomycin Injection Premix with 16 months of shelf life. In addition, this should move the product closer to the patients which may reduce time to delivery in urgent, emergency needs.”
Full prescribing information for Vancomycin Injection Premix RTU can be found at www.xellia.com/us
About Vancomycin Injection
Vancomycin Injection, Ready to use (RTU) is a proprietary formulation of vancomycin, provided as a premixed solution in single-dose flexible bags, stable at room temperature (up to 25 °C) for 16 months.
Vancomycin Injection RTU is provided as 100 mL, 200 mL, 300 mL or 400 mL solution containing 500 mg, 1 g, 1.5 g or 2 g vancomycin, respectively. Each 100 mL of solution contain 1.8 mL polyethylene glycol 400, 1.36 g N-acetyl-D-alanine, and 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment.
Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: septicaemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections.
The FDA approval of this novel vancomycin formulation was obtained on the basis of more than 60 non-clinical experiments, including studies to confirm that the new formulation does not adversely impact the efficacy profile of the active ingredient, vancomycin. The product safety profile has been extensively evaluated in vitro and in vivo, including 5 repeat dose toxicity studies of the novel vancomycin formulation in rats and dogs with dosing up to 13 weeks, in addition to full safety qualification of excipient N-acetyl-D-alanine including safety pharmacology and repeat dose toxicity studies in 2 animal species with dosing up to 13 weeks, and animal reproduction studies of N-acetyl-D-alanine and polyethylene glycol 400.
IMPORANT SAFETY INFORMATION
WARNING: RISK OF EMBRYO-FETAL TOXICITY DUE TO EXCIPIENTS
This formulation of Vancomycin Injection is not recommended for use during pregnancy because it contains the excipients polyethylene glycol (PEG 400) and N-acetyl D-alanine (NADA), which caused fetal malformations in animal reproduction studies. If use of vancomycin is needed during pregnancy, use other available formulations of vancomycin. (5.1, 8.1)
WARNINGS AND PRECAUTIONS
- Infusion Reactions: Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular and chest pain and “red man syndrome” which manifests as pruritus and erythema that involves the face, neck and upper torso may occur with rapid intravenous administration. To reduce the risk of infusion reactions, administer Vancomycin Injection over a period of 60 minutes or greater and also prior to intravenous anesthetic agents. (2.1, 5.2)
- Nephrotoxicity: Systemic vancomycin exposure may result in acute kidney injury (AKI) including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. Monitor serum vancomycin concentrations and renal function. (5.3)
- Ototoxicity: Ototoxicity has occurred in patients receiving vancomycin. Monitor for signs and symptoms of ototoxicity during therapy. Monitor serum vancomycin concentrations and renal function. Assessment of auditory function may be appropriate in some instances. (5.4)
- Clostridium Difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs. (5.5).
- Neutropenia: Periodically monitor leukocyte count. (5.7)
- Phlebitis: To reduce the risk of local irritation and phlebitis administer Vancomycin Injection by a secure intravenous route of administration. (5.8)
- Development of Drug-Resistant Bacteria: Prescribing Vancomycin Injection in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. (5.9)
The common adverse reactions are anaphylaxis, “red man syndrome”, acute kidney injury, hearing loss, neutropenia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Xellia Pharmaceuticals USA, LLC at 1-833-295-6953 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Anesthetic Agents: Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing. (2.1, 7.1)
- Piperacillin/Tazobactam: Increased incidence of acute kidney injury in patients receiving concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients (7.2)
Please see full Prescribing Information, including Boxed WARNING (1).
1. Vancomycin Injection Full Prescribing Information (U.S.). Feb 2019, Xellia Pharmaceuticals ApS.
About Xellia Pharmaceuticals
Xellia Pharmaceuticals (“Xellia”) is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections.
With over 100 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable drug products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia and North America and is investing significantly to expand its sales and manufacturing capabilities within the United States. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,600 people.
Further information about Xellia can be found at: www.xellia.com.