The US Food & Drug Administration’s (FDA) panel has given its nod to drug maker Actavis plc for its experimental antibiotic, named ceftazidime-avibactam, to treat severe lower abdominal infections caused by the drug resistant bacteria.
The antibiotic medication received green signal from FDA’s Anti-Infective Drugs Advisory Committee for treating complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
Actavis and AstraZeneca plc are jointly developing the drug. Under the agreement, Actavis owns the drug’s rights in North America, while AstraZeneca has the rights in other countries.
The committee’s decision came after the drug showed promising results during the Phase II clinical trials. During the trial, the drug showed its efficacy and safety for successfully treating patients in hospital who are suffering from the bacterial infections like cIAI and cUTI.
The FDA panel, however, denied permission to the drug maker for the antibiotic’s usage in treating patients with bacteremia, hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).
The committee took decision in dearth of satisfactory results from the clinical trial to prove the efficacy of ceftazidime-avibactam to treat those infections. Moreover, the FDA panel was also skeptical about the administering of the antibiotics to patients having renal impairment.
According to the experts, the recommendations made by the Advisory Committee are not binding on the FDA. The health regulatory authority, however, considers the panel’s suggestions but the final decision on approval of any drug completely rests in its hands.
The health regulatory authority is expected to deliver its decision on ceftazidime-avibactam New Drug Application (NDA) in the first quarter of 2015.
The FDA nod has come as an encouraging development for Actavis as the sale of the antibiotics can immensely contribute in increasing the company’s revenues manifold.