Allergan Announces FDA Approval of Updated Label for TEFLARO® (ceftaroline fosamil)

DUBLIN, Sept. 2, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental new drug application (sNDA) to update the label for TEFLARO® (ceftaroline fosamil) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The approved label contains new clinical data from two ABSSSI trials that included patients with baseline Staphylococcus aureus bacteremia. Bacteremia is the presence of bacteria in the bloodstream. Bacteremia complicates infection treatment and in the most serious cases, can be fatal.

With this updated label, TEFLARO also is now approved to be administered by intravenous (IV) infusion in five minutes to one hour in adult patients 18 years and older.

"The new clinical data in the TEFLARO label will allow for use in ABSSSI patients with baseline S. aureus bacteremia, the incidence of which has increased sharply in recent years, and provides physicians with the ability to treat patients with these serious infections," said David Nicholson, Executive Vice President & President, Global Brands Research and Development, Allergan. "In addition, with a shorter infusion time TEFLARO provides increased flexibility in dosing that may allow physicians, nurses and other healthcare professionals to optimize the delivery of care in hospital and home settings."

Updated ABSSSI Trial Data

The sNDA approval was based on a subset of data coming from two identical pivotal trials (CANVAS 1 and 2) comparing ABSSSI patients treated with TEFLARO monotherapy to patients treated with vancomycin plus aztreonam. Of the 693 patients in the modified intent-to-treat (MITT) population in the TEFLARO arm in the two ABSSSI trials, 20 patients had baseline Staphylococcus aureus bacteremia (nine cases of methicillin-resistant Staphylococcus aureus [MRSA] and 11 cases of methicillin-susceptible Staphylococcus aureus [MSSA]). Thirteen of these 20 patients (65%) achieved clinical response with TEFLARO at Day 3 and 18 of 20 patients (90%) were considered clinical success at Test of Cure. This data is now included in the clinical trial section of the Teflaro prescribing information.

Updated Dosing Time

TEFLARO can now be administered in 5 minutes to one hour in the treatment of patients with ABSSSI and CABP due to designated susceptible pathogens. Recommended dosing for TEFLARO is 600 mg IV for 5 to 60 minutes by IV every 12 hours for 5 to 14 days for ABSSSI and 5 to 7 days for CABP.

Patients with renal impairment should receive TEFLARO in a 5 to 60 minute IV infusion every 12 hours at the following dosages:

• >50 CrCl (mL/min): 600 mg
• >30 to <50 CrCl (mL/min): 400 mg
• >15 to <30 CrCl (mL/min): 300 mg
• End-stage renal disease (CrCl < 15 mL/min), including hemodialysis: 200 mg

ABOUT TEFLARO® (ceftaroline fosamil)

TEFLARO was first approved by the U.S. FDA in October 2010 for the treatment of adults with CABP and ABSSSI due to designated susceptible pathogens. TEFLARO is a bactericidal cephalosporin with activity against both Gram-positive and Gram-negative pathogens. TEFLARO is indicated for the treatment of CABP, including cases caused by Streptococcus pneumoniae , and ABSSSI, including cases caused by methicillin-resistant Staphylococcus aureus (MRSA). TEFLARO is the first and only cephalosporin with activity against MRSA. In clinical trials, TEFLARO was generally well-tolerated with an adverse event profile consistent with the cephalosporin class of antibiotics. TEFLARO has been administered in over 2.3 million days of therapy, treating more than 350,000 patients.

Forest obtained the worldwide rights (excluding Japan, where Takeda Pharmaceuticals holds rights) to TEFLARO in 2007 when it acquired Cerexa, Inc., a privately held biopharmaceutical company. In August 2009, Forest Laboratories and AstraZeneca (NYSE: AZN) entered into a definitive collaboration agreement to co-develop and commercialize ceftaroline fosamil in all markets outside the U.S., Canada and Japan.

INDICATIONS AND USAGE

TEFLARO is indicated for the treatment of acute ABSSSI caused by susceptible bacterial isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and -resistant isolates) Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae and Klebsiella oxytoca.

TEFLARO is also indicated for the treatment of CABP caused by susceptible bacterial isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEFLARO and other antibacterial drugs, TEFLARO should be used to treat only ABSSSI or CABP that are proven or strongly suspected to be caused by susceptible bacteria.

Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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