The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Eraxis (anidulafungin) is an echinocandin semi-synthetic
lipopetide, designed to eradicate fungal infections through
disruption of enzyme synthesis pathways in these cells without
affecting human tissues.
Eraxis is specifically indicated for the treatment of several
types of fungal infections: Candidemia; intra-abdominal abscess and
peritonitis caused by Candida species; and esophageal
candidiasis. The drug has not been studied for the treatment of
Candida related endocarditis, osteomyelitis, or
meningitis, and efficacy in the treatment of neutropenic patients
has not been fully established.
Eraxis is supplied as a lyophilized powder for reconstitution
and injection. The recommended initial dose of the drug for the
treatment of Candidemia/additional Candida infections is a
single loading dose of 200 mg Eraxis on day 1, followed by 100 mg
daily thereafter, until clinical response is observed (generally
through at least 14 days after the last positive fungal culture).
For esophageal candidiasis, recommended dosing is a single loading
dose of 100 mg on day 1, followed by 50 mg daily thereafter for at
least 14 days and at least 7 days following the resolution of
Candidemia/Additional Candida Infections
Approval of Eraxis for the treatment of Candidemia and additional
Candida infections was based on a phase III trial. This
randomized, double-blind, controlled study treated 256 patients
with candidemia and/or other forms of invasive candidiasis.
Subjects received a fixed dose regimen of either Eraxis (200 mg
loading dose/100 mg daily maintenance dose) or fluconazole (800 mg
loading dose/400 mg daily maintenance dose) via intravenous
infusion for 14 to 42 days. Patients from either arm were permitted
to transfer to oral fluconazole following at least 10 days of IV
therapy and a negative blood culture. At the end of IV treatment,
treatment 75.6% of subjects receiving Eraxis achieved global
clinical success, vs. 60.2% for fluconazole. Superiority was
maintained at the end of all treatment, (74.0% global success, vs.
56.8%, respectively), and at 2-week (64.6% vs. 49.2%) and 6-week
(55.9% vs. 44.1%) follow-ups. All-cause mortality during the study
(22.8% vs. 31.4%) all cause mortality during study therapy (7.9%
vs. 14.4%), and mortality attributed to Candida (1.6% vs.
4.2%) all showed reductions for Eraxis relative to fluconazole.
Approval of Eraxis for the treatment of esophageal candidiasis was
based on a double-blind, double-dummy, randomized phase III trial.
601 subjects were randomized to receive Eraxis (100 mg loading
dose/50 mg daily maintenance dose) or fluconazole (200 mg loading
dose/100 mg daily maintenance dose) via intravenous infusion.
Treatment was administered for a minimum of 14 days, and for 7 days
following the resolution of symptoms, through a maximum of 21 days.
In both treatment groups, median time to resolution of symptoms was
5 days, and median duration of therapy was 14 days. Endoscopic
success (the combined rate of clinical improvement and cure) at the
end of therapy (the trial's primary endpoint) was 97.4% for
Eraxis and 98.7% for fluconazole; this included cure rates of 88.3%
vs. 93.6%, respectively, and improvement rates of 9.1% vs. 5.1%. At
2-weeks post-treatment subjects receiving Eraxis experienced
significantly more endoscopically-documented relapses (53.3%) than
subjects receiving fluconazole (19.3%).
Ongoing Study Commitments
- Deferred pediatric study under PREA for the treatment of
candidemia and other forms of Candida infections (intra-abdominal
abscess and peritonitis) in pediatric patients ages zero months to
sixteen years of age.
Final Report Submission: February 17, 2011
Adverse events associated with the use of Eraxis may include,
but are not limited to, the following:
- Liver Enzyme Abmormalities
Mechanism of Action
Anidulafungin is a semi-synthetic echinocandin designed to
inhibit glucan synthase, an enzyme present in fungal (but not
mammalian) cells. Inhibition of glucan synthase disrupts formation
of 1,3-ß-D-glucan, an essential component of the fungal cell
Turner MS, Drew RH, Perfect JR Emerging
echinocandins for treatment of invasive fungal infections.
Expert Opinion on Emerging Drugs 2006 May;11(2):231-50
Benjamin DK Jr, Driscoll T, Seibel NL, Gonzalez CE,
Roden MM, Kilaru R, Clark K, Dowell JA, Schranz J, Walsh
TJ Safety and pharmacokinetics of intravenous
anidulafungin in children with neutropenia at high risk for
invasive fungal infections. Antimicrobial Agents and
Chemotherapy 2006 Feb;50(2):632-8
Karlowsky JA, Hoban DJ, Zhanel GG, Goldstein BP
In vitro interactions of anidulafungin with azole antifungals,
amphotericin B and 5-fluorocytosine against Candida species.
International Journal of Antimicrobial Agents 2006
Feb;27(2):174-7. Epub 2006 Jan 18
Pfaller MA, Diekema DJ, Boyken L, Messer SA, Tendolkar
S, Hollis RJ, Goldstein BP Effectiveness of anidulafungin
in eradicating Candida species in invasive candidiasis.
Antimicrobial Agents and Chemotherapy 2005
For additional information regarding Eraxis or Candida
fungal infections, please visit the