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EMA accepts Cubist antibiotic for review

Follows FDA priority review for ceftolozane/ tazobactam

Cubist pharmaA new antibiotic to treat infections took a step closer to approval in Europe after regulators accepted the drug for review.

Ceftolozane/tazobactam is developed by antibiotic specialist Cubist Pharmaceuticals and is now under assessment for use in the treatment of complicated urinary tract Infections and complicated intra-abdominal infections.

A decision by the European Medicines Agency (EMA) on the use of the drug in the region is expected in second half of 2015.

The announcement follows the US FDA's decision in June this year to appraise ceftolozane/tazobactam under priority review in this indication.

Both the EU and US reviews will consider data provided by Cubist from two phase III trials involving the antibiotic, which the company says met primary endpoints specified by both agencies.

Resistance to current antibiotics is widely acknowledged as one of the greatest global public health threats and approval for ceftolozane/tazobactam would be a major boost to a market where new treatments are sorely needed.

The problem has been exacerbated as many companies have dropped out of developing new antibiotic treatments due to the poor return on investment.

Cubist is one of the few companies still investing in the area and recently received FDA approval for another antibiotic - Sivextro (tedizolid phosphate) - for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Commenting on the EMA's decision to review ceftolozane/tazobactam, Cubist's chief scientific officer Steve Gilman said: “As we continue to expand globally, this advancement further positions Cubist to respond to growing health threats and reinforces our commitment to bring new antibiotics to patients worldwide facing serious infections, including those caused by Gram-negative bacteria.”

Governments across the world seem to be waking up to the need for more antibiotics, however, including the UK's recently launched review to explore the economic issues surrounding antimicrobial resistance to find ways to improve the research environment.

UK professional bodies have also urged better use of antibiotics on the NHS, while the US FDA is supporting the regulatory process for new drugs via Antibiotic Incentives Now (GAIN) Act, launched in 2012.

Article by
Thomas Meek

27th August 2014

From: Sales, Healthcare



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