SIVEXTRO™ (tedizolid phosphate) is a once daily oxazolidinone being developed for both intravenous (I.V.) and oral administration for the potential treatment of complicated skin and soft tissue infections (cSSTI). In February 2014, the Company announced that the European Medicines Agency (EMA) accepted the tedizolid Marketing Authorization Application for review, with a decision expected from the European Commission (EC) during the first half of 2015.
Tedizolid is also being developed for potential use in HABP/VABP, with Phase 3 pivotal studies progressing.
About Serious Skin, Skin Structure and Soft Tissue Infections
Acute bacterial skin and skin structure infections (ABSSSI) are also referred to as complicated skin and soft tissue infections (cSSTI) (in Europe). These infections, which are a significant and growing problem throughout the world, involve deeper tissue or require surgical intervention (e.g., cellulitis, major cutaneous abscesses and infected wounds) or are associated with a significant underlying disease (e.g., diabetes or systemic immunosuppression) that complicates response to therapy. A variety of pathogens may be identified in ABSSSI/cSSTI but the two most common Gram-positive pathogens are Staphylococcus aureus and Streptococcus pyogenes. The significant increase in the incidence of methicillin-resistant Staphylococcus aureus (MRSA) healthcare-associated infections (HAIs), as well as community infections, has resulted in a need for therapies to address serious skin, skin structure and soft tissue infections that are effective against MRSA.