daptomycin

Under terms of the agreement, Teva Pharmaceuticals may launch its generic daptomycin product in the U.S. on June 24, 2018 if Cubist Pharmaceuticals obtains a 6 month extension of marketing exclusivity.

Cubist Reaches Drug Licensing Deal With Teva 2011

Cubicin, which is daptomycin for injection, is approved in the U.S. to treat staphylococcus aureus bloodstream infections including right-side endocarditis.

Cubist Reaches Drug Licensing Deal With Teva 2011

A decision was clearly needed: according to company data, 150,000 patients had received daptomycin in the two and a half years since the first approval, and probably one-fourth of them had been off-label treatment for bacteremia that was not treatable by existing drugs.

SUPERBUG MARYN MCKENNA 2010

When daptomycin entered the lung, it mistook the surfactant-coated surfaces for bacteria and bound to them, using up the drug before it could attack the organisms it was aimed at.

SUPERBUG MARYN MCKENNA 2010

The FDA had just changed its standard from 20 percent to 10 percent; a year earlier, with the same data, daptomycin would have passed the test.

SUPERBUG MARYN MCKENNA 2010

In the end, however, they recommended the FDA approve the drug, voting 9–0 to license daptomycin for treatment of bacteremia and splitting 5–4 for endocarditis on the right side of the heart.43

SUPERBUG MARYN MCKENNA 2010

The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections.

SUPERBUG MARYN MCKENNA 2010

The FDA committee members pressed the Cubist representatives with questions, about stubborn bloodstream infection, the potential for daptomycin MICs to rise, and deaths among participants.

SUPERBUG MARYN MCKENNA 2010

At Cubist, the thought at first was that daptomycin could be a topical antibiotic against MRSA skin infections, or an oral drug that would send its potent antibacterial action into the gut to combat resistant enterococci.

SUPERBUG MARYN MCKENNA 2010

It has developed several types of resistance to vancomycin, a glycopeptide, which for decades was the MRSA drug of last resort, and is beginning to exhibit resistance to drugs in newly developed families that were intended to replace vancomycin: linezolid (Zyvox), an oxazolidinone, and daptomycin (marketed as Cubicin), a lipopeptide.

SUPERBUG MARYN MCKENNA 2010