Pfizer Europe Emblaveo (aztreonam / avibactam) Receives Approval in Europe
Pfizer is stepping up with a rare antibiotics buyout deal today, grabbing Palo Alto, CA-based Arixa Pharmaceuticals in a bid to add a new oral version of avibactam, a beta lactamase inhibitor — or BLI — approved back in 2015 as part of the IV treatment Avycaz.
This summer, Pfizer teamed up with other Big Pharmas on a $1 billion fund to bolster struggling antibiotics makers. Now, the company is adding a new antibiotic candidate to its pipeline through its acquisition of Arixa. If approved, the prospect could be the first new drug of its kind in more than 35 years.
Allergan plc (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation for ATM-AVI (aztreonam and avibactam), for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), and hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP). ATM-AVI is an investigational, fixed-dose, intravenous combination antibiotic under development globally.
Allergan has won US approval for its fixed-dose combination antibiotic Avycaz in a new indication, becoming the first new drug to treat pneumonia caused by Gram-negative bacterial infections in more than 15 years.
DUBLIN, Feb. 1, 2018 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Allergan's supplemental New Drug Application (sNDA) to expand the approved use of AVYCAZ® (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years of age or older. This expanded use is based on positive results from a pivotal Phase 3 study evaluating the efficacy and safety of AVYCAZ for the treatment of adult patients with HABP/VABP. The sNDA received priority review from FDA based on the Qualified Infectious Disease Product (QIDP) designation for the HABP/VABP indication.