You can think of dalbavancin as a second generation vanco but there are some unique properties, particularly its pharmacokinetics which enable once weekly dosing.
Dalvance is the first drug to benefit from the FDA's new fast track process for antibiotics. From the FDA bulletin:
Dalvance is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Dalvance was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections.
“Today’s approval demonstrates the FDA’s commitment to encouraging increased development and approval of new antibacterial drugs, providing physicians and patients with important new treatment options,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
As part of its QIDP designation, Dalvance was given priority review, which provides an expedited review of the drug’s application. Dalvance’s QIDP designation also qualifies it for an additional five years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug and Cosmetic Act.
Here are a few of my questions and concerns:
There was a mild signal of liver toxicity in clinical trials.
It will probably be very expensive.
Given the many options for gram positive infections that we already have exactly where will this drug fit in?
The drug's approval is narrow in scope. What off label uses might be appropriate as we gain more experience?
Many patients with skin infections do not need MRSA coverage at all. That's a matter for clinical judgment.
I don't anticipate heavy usage of this drug. It's one more option, which is great.
The concluding comments of the Academic Life in Emergency Medicine post came across to me as a little hard line:
Even if the company adjusts the price to less than $100 per dose, hospital antimicrobial stewardship programs need to rationalize and limit the use of this new antibiotic for cases when cheaper non-inferior treatments have failed.
Rationalize? How rational is it to wait for treatment failure before considering another option that might be better for the patient? He goes on:
Advertisers’ persuasion of better compliance for “high-risk patients,” convenience, and non-inferiority, are not enough to challenge the standard care of SSTIs in the ED.
Not enough to even challenge standard care? It seems to me that the convenience advantage is pretty substantial. This is an illustration of the difference between two approaches to medicine: medicine by committee and evidence based medicine (EBM). The author of the post is advocating medicine by committee. It's incompatible with EBM because it proscribes two of EBM's essential components in decision making about whether to use dalbavancin: the individual patient's unique attributes, preferences and values and the judgment and expertise of the treating clinician.