Tedizolid

703914008

New Medicines

Sivextro Acute bacterial skin and skin structure infections (ABSSSI) in adolescents 12 years of age and older

Information

Sivextro
Licence extension / variation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

Launched
Launched
None
July 2020
Jul 20Approved in the EU [2]
May 20EU positive opinion for a licence change to include treatment of adolescents. The new indication is treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older [1].

Category

Oxazolidinone - ribosomal protein inhibitor
Skin and soft tissue infections (SSTIs) are common, and complicated SSTIs (cSSTIs) are the more extreme end of this clinical spectrum, encompassing a range of clinical presentations such as deep-seated infection, a requirement for surgical intervention, the presence of systemic signs of sepsis, etc. The vast majority of SSTIs are caused by S. aureus and β-haemolytic streptococci, usually Lancefield groups A, C and G, with group B occurring in diabetics and the elderly.
Acute bacterial skin and skin structure infections (ABSSSI) in adolescents 12 years of age and older
Oral and
Intravenous infusion

Evidence based evaluations

SivextroGram-positive hospital-acquired bacterial pneumonia (HABP) or gram-positive ventilator-associated bacterial (VABP), collectively defined as ventilated nosocomial pneumonia (VNP) - first-line

Information

Sivextro
Licence extension / variation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Jul 19No longer listed in Merck pipeline; development plans uncertain [14].

Category

Second-generation oxazolidinone - ribosomal protein inhibitor
In a 2011 survey of 52,443 patients in 99 NHS trusts in England, the prevalence of hospital-associated pneumonia (HAP) or lower respiratory tract infection was 1.5%. Of these cases, 798 patients had HAP. Approximately 65% of HAP cases are not associated with intubation. HAP is estimated to increase hospital stays by 79 days and has a mortality of between 30 and 70%.
Gram-positive hospital-acquired bacterial pneumonia (HABP) or gram-positive ventilator-associated bacterial (VABP), collectively defined as ventilated nosocomial pneumonia (VNP) - first-line
Intravenous