The FDA has approved a new antibacterial from Actavis, bringing the tally of new antibiotics cleared in the US to five in the last few months.
The go-ahead for Avycaz – which is based on the established cephalosporin antibiotic ceftazidime and avibactam, a new beta lactamase inhibitor to help prevent resistance development – provides a fresh option for hard-to-treat infections.
The US regulator has approved Avycaz for adults with complicated intra-abdominal infections (cIAI) – in combination with metronidazole – as well as for complicated urinary tract infections (cUTI). It was originally developed by Forest Laboratories, which was acquired by Actavis in a $25bn deal last year, and is now scheduled for launch in the second quarter of this year.
It is the fifth new antibiotic approved under the FDA’s Qualified Infectious Disease Product (QIDP) – which rewards companies who develop new antibacterials with five years’ additional market exclusivity – since the start of 2014.
Avycaz’ closest rival among these is Cubist Pharmaceuticals’ Zerbaxa (ceftolozane/tazobactam) – which has been tipped as a $1bn-plus product – while the others are Cubist’s Sivextro (tedizolid), Durata/Actavis’ Dalvance (dalbavancin) and The Medicine Company’s Orbactiv (oritavancin).
The FDA wants the new product to be reserved for use in patients battling resistant infections that are not responding to other drugs. Actavis recently predicted that Avycaz would be a $250m to $500m product, perhaps reflecting that last-line use.
“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,” commented Edward Cox, who heads up the FDA’s Office of Antimicrobial Products.
At the end of last year, a review on antimicrobial resistance warned that it could result in 10 million extra deaths a year by 2050 if action is not taken, with the cost associated with resistance hitting $100tn by that date.
The US approval is also good news for Actavis co-development partner for avibactam AstraZeneca (AZ), which owns rights to avibactam outside North America. AZ is developing it alongside other cephalosporin antibiotics, notably ceftaroline, which is the active ingredient in its injectable Zinforo product that was approved in Europe in 2012.
AZ has been touting around for ways to spin out its antibiotics business but has met with limited success, reportedly because it is trying to retain 50% ownership of the unit, which is making it less attractive to potential partners or investors.