The US Food & Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee has prescribed trail anti-biotic, ceftazidime-avibactam from Actavis plc for treating intricate intra-abdominal diseases (cIAI) and convoluted urinary tract diseases (cUTI) brought on by drug resistant bacteria.
The medication has been co developed by Actavis and Astrazeneca plc under an agreement which gives Actavis the rights of the medication in North America while Astrazeneca holds the rights for it in other nations.
The advisory group’s verdict hinged around the drug passing Phase II clinical trials with efficacy in treating hospital patients with cIAI or cUTI when no other treatment is available.
However the anti-biotic failed to get the board of trustees’ nod for treating hospital-acquired bacterial pneumonia (HABP), ventilator-acquired bacterial pneumonia (VABP), and bacterecemia. The panel was not convinced about ceftazidime-avibactam’s efficiency focused around the clinical trials information accommodated for these signs.
The panel’s proposal is however not obligatory on the FDA, it has the power to take a decision on the drug’s endorsement; it still actively considers the panel’s conclusions.
Ceftazidime-avibactam got qualified infectious disease product (QIDP) status from the FDA. This made it eligible for FDA’s fast track program and 5 years marketing uniqueness. Thus this project encourages the improvement and administrative methodology of medications which has been created for treating life threatening infections.
Actavis had in August declared that the drug’s Phase III trials, Reclaim-1 and Reclaim-2 as positive. The trials were focused on the ceftazidime-avibactam’s adequacy and safety in patients with cIAIs. The trials revealed that the medication met the aim of non-inferior treatment in comparison with meropenem.
The latest Advisory Panel’s recommendation is welcome news for Actavis and it could make a huge profit if the FDA supports the medication for treating cIAIs.