CHMP Says Yes to Two Antibiotics for Skin Infections

Megan Brooks

January 23, 2015

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of two antibiotics for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI): oritavancin (Orbactiv, The Medicines Co) and tedizolid phosphate (Sivextro, Cubist Pharmaceuticals).

The benefits of oritavancin (400 mg powder for concentrate solution for infusion) are "its ability to effectuate cure of ABSSSI with a single intravenous (IV) dose," the EMA said in a news release.

"In two identical designed pivotal trials (SOLO 1 and SOLO 2), oritavancin showed non-inferiority versus vancomycin comparator, for early clinical response (cessation of spread or reduction in size of the lesion) and clinical cure rates," the EMA said.

The most common adverse effects with oritavancin, which is a glycopeptide antibacterial, are nausea, hypersensitivity reactions, infusion site reactions, and headache.

Tedizolid phosphate (200 mg film-coated tablet, powder for concentrate for solution for infusion) is a new oxazolidinone.

"The benefits with Sivextro are its ability to be active against important Gram-positive pathogens that are common etiological agents of ABSSSI, including methicillin-resistant [Staphylococcus] aureus (including linezolid-resistant strains), as well as pathogenic streptococci," the EMA said.

The most common adverse effects are nausea, headache, diarrhea, and vomiting.

On the basis of quality, safety and efficacy data submitted, the CHMP considers there to be a "favorable benefit-to-risk balance" for oritavancin and tedizolid phosphate for ABSSSI, and therefore it recommended the granting of the marketing authorization.

A pharmacovigilance plan for both agents will be implemented as part of the marketing authorization.

Detailed recommendations for the use of both drugs will be described in the summary of product characteristics, which will be published in the European public assessment report and made available after the marketing authorization has been granted by the European Commission.

The US Food and Drug Administration approved oritavancin in August 2014 and approved tedizolid phosphate in June for adults with ABSSSI caused by certain susceptible bacteria such as S. aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species, and Enterococcus faecalis.

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