Generic Skin Infection Drug Launched

Teva has just launched daptomycin for injection, a generic version of Cubicin, in the US market.

The antibacterial drug is indicated to treat complicated skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria:

• Staphylococcus aureus (including methicillin-resistant isolates)
• Streptococcus pyogenes
• S. agalactiae
• S. dysgalactiae subspecies equisimilis
• Enterococcus faecalis (vancomycin-susceptible isolates only).

Daptomycin is also indicated for the treatment of S. aureus bloodstream infections, including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. However, it is not indicated for the treatment of left-sided infective endocarditis due to S. aureus, and it has not been studied in patients with prosthetic valve endocarditis. The drug is also not indicated to treat pneumonia.

To reduce the development of drug-resistant bacteria and maintain drug effectiveness, daptomycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, it should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy, which may be initiated while awaiting test results.

Adverse effects associated with daptomycin include myopathy and rhabdomyolysis, eosinophilic pneumonia, peripheral neuropathy, potential nervous and/or muscular system effects in patients younger than 12 months, and Clostridium difficile-associated diarrhea. Patients with persisting or relapsing S. aureus bacteremia/endocarditis, possibly due to reduced daptomycin susceptibility, or poor clinical response should have repeat blood cultures. Additionally, decreased efficacy was observed in daptomycin-treated patients with moderate baseline renal impairment (CrCL <50 mL/min).

Daptomycin for injection had annual sales of approximately $1.2 billion in the United States, according to IMS data as of July 2016.