European Commission Approves Pfizer’s EMBLAVEO® for Patients with Multidrug-Resistant Infections and Limited Treatment Options
Hospira, Inc`s Generic Aztreonam Receives Approval In US
Hospira, Inc’s Generics Aztreonam Receives Approvals In US
When patented, brand-name antibiotics lose market exclusivity, generics typically enter the market at lower prices, which may increase consumption of the drug. To examine the effect of generic market entry on antibiotic consumption in the United States, we conducted an interrupted time series analysis of the change in the number of prescriptions per month for antibiotics for which at least one generic entered the US market between 2000 and 2012. Data were acquired from the IQVIA Xponent database. Thirteen antibiotics were analyzed. Here, we show that one year after generic entry, the number of prescriptions increased for five antibiotics (5 to 406%)—aztreonam, cefpodoxime, ciprofloxacin, levofloxacin, ofloxacin—and decreased for one drug: cefdinir. These changes were sustained two years after. Cefprozil, cefuroxime axetil and clarithromycin had significant increases in trend, but no significant level changes. No consistent pattern for antibiotic use following generic entry in the United States was observed.
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.
Basilea is halfway towards filing for approval of its broad-spectrum antibiotic ceftobiprole for serious skin infections in the US, after clearing the first of two phase 3 trials.
Enforcement Report - Week of May 16, 2018
Ligand Pharmaceuticals Incorporated partner Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, announced that it has submitted New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for approval of IV and oral Baxdela (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI).
The US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and AstraZeneca, a global biopharmaceutical company, have entered into a private partnership agreement to develop multiple drugs to combat bioterrorism threats and other life-threatening bacterial infections.
Close to 18 months after AstraZeneca ($AZN) decided to jettison its early-stage anti-infectives division and the 180 staffers that were then working in the Massachusetts-based group, the pharma giant is stepping back up in the field, with the feds footing up to $220 million in research costs to hunt down new antibiotics.