Actavis’ new antibiotic Avycaz approved in US

The FDA has approved Actavis’ antibotic Avycaz, a new treatment for adults with complicated intra-abdominal infections (cIAI) (in combination with metronidazole) and complicated urinary tract infections (cUTI).

The drug is the latest in a string of new antibiotics to be approved by the FDA for difficult-to-treat infections – novel treatments which are sorely needed, as experts are warning that the spread of drug-resistant bacteria is a huge risk to public health.

For Actavis, the new approval helps it extend its presence in the field – having bought Durata Therapeutics along with its recently approved antibiotic Dalvance (dalbavancin) in October. Avycaz was developed by Forest, another company which the M&A hungry Actavis acquired in 2014.

Avycaz contains two drugs: ceftazidime, a previously approved cephalosporin antibacterial, and avibactam, to help extend bacterial resistance.

“The FDA is committed to making therapies available to treat patients with unmet medical need,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “It is important that the use of Avycaz be reserved to situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.”

The drug received a priority review based on Phase II data from the company’s clinical development programme and supporting in vitro data, and benefits from the FDA’s Qualified Infectious Disease Product (QIDP) scheme.

The QIDP designation also qualifies Avycaz for an additional five years of marketing exclusivity to be added to the five-year exclusivity period provided by the Food, Drug, and Cosmetic Act.

The drug is the fifth to be approved through the QIDP system. No fewer than four were approved in 2014: Cubist’s Zerbaxa (ceftolozane/tazobactam) and Sivextro (tedizolid) Durata/Actavis’ Dalvance (dalbavancin) and The Medicines Company’s Orbactiv (oritavancin).

For Actavis, the new approval adds to its momentum, and helps push it onto its next stage of growth. The company is just finalising its takeover of Botox-manufacturer Allergan, whose name it will assume once the acquisition is complete.

The company is focusing on four key therapy areas – GI, CNS, Women’s Health and Anti-infectives – and says nine compounds in mid or late-stage development could generate more than $6 billion in peak sales following launch.

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