Cubicin approved for marketing in Canada

The approved label includes both complicated skin and skin structure infections caused by certain gram positive infections, at an approved dose of 4 mg/kg, and bloodstream infections, including right-sided infective endocarditis, caused by Staphylococcus aureus, at an approved dose of 6 mg/kg.

Oryx president Doug Reynolds said: “There is a great need in Canada for new approved therapies to treat serious, sometimes life-threatening infections, particularly those caused by methicillin-resistant Staphylococcus aureus. We look forward to our commercial launch of the drug, and expect that cubicin will quickly become an essential part of the infectious disease armamentarium in Canada.”

Oryx expects to formally launch cubicin in Canada by late November. While undergoing the regulatory review process, cubicin has been available to Canadian healthcare institutions, when requested, through Health Canada’s Special Access Programme (SAP) which provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP will remain active until Canadian inventory is in stock in the Oryx distribution system.

Cubicin, originally introduced in the US in 2003 and approved for an expanded US label in 2006, already has been used to treat more than an estimated 370,000 patients in the US. Other international markets where cubicin has received regulatory approval for multiple indications include the EU, Switzerland, Taiwan, South Korea, and Israel. Cubist markets Cubicin in the US through its own commercial organization and has licensed the drug for marketing in all other parts of the world.