Regulators in the USA have given the green light to Cubist Pharmaceuticals’ antibiotic Sivextro for serious skin infections, including those caused by MRSA.
The US Food and Drug Administration has approved Sivextro (tedizolid) for acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (MRSA) and enterococcus faecalis. The thumbs-up is based in two trials of 1,315 adults with ABSSSI which showed that Sivextro was as effective as linezolid, another antibacterial.
Cubist says the once-a-day drug offers a short six-day course of therapy is available for both intravenous and oral use. The approval was expected, given that the FDA’s Anti-Infective Drugs Advisory Committee voted 14-0 in March to recommend Sivextro which was designated as a qualified infectious disease product and received an expedited review; this also means an additional five years of marketing exclusivity.
The approval means that Cubist has added to its already-marketed antibacterials, notably Cubicin (daptomycin) and Dificid (fidaxomicin). Chief executive Michael Bonney noted that “the oral option provides opportunity for out-patient care, which could reduce the need for costly hospitalisation”.
He added that Sivextro is one of “at least four antibiotics Cubist hopes to deliver in support of the Infectious Diseases Society of America challenge to industry and policy makers to develop and approve 10 new antibiotics by 2020”. Cubist recently submitted its investigational antibiotic ceftolozane/tazobactam to the FDA for the treatment of cmplicated urinary tract and intra-abdominal infections.
Sivextro is the second new antibacterial approved by the FDA in the past month to treat ABSSSI, having just given the green light to Durata Therapeutics’ Dalvance (dalbavancin).
