Ecalta (anidulafungin) Recommended For Use In NHS Scotland - Antifungal For Invasive Candidiasis

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Dermatology;  Infectious Diseases / Bacteria / Viruses
Article Date: 10 Nov 2008 - 8:00 PDT

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Pfizer Limited today welcomes the Scottish Medicines Consortium (SMC) advice, which recommends Ecalta® (anidulafungin), a new antifungal medicine for the treatment of invasive candidiasis in NHS Scotland.1

Following a re-submission, the SMC's decision to recommend anidulafungin comes after results of the cost-minimisation analysis which indicated that anidulafungin would be preferred to both caspofungin and liposomal amphotericin B, with savings of £772 and £2,375 respectively, as a second-line treatment option.1

Anidulafungin has been shown to be at least as effective as fluconazole in a study of 245 patients, the majority of whom had candidaemia. Its use is restricted to adult non-neutropenic patients who are unable to tolerate fluconazole or have invasive candidiasis that is resistant to fluconazole.1

In addition to the cost benefits and equivalent efficacy, anidulafungin has advantages over existing treatments - with no dose adjustments required in patients with renal or hepatic impairment. It has the added benefit of no known drug interactions.1

Dr David Gillen, Medical Director, Pfizer Limited, said: "We are delighted that the SMC has recognised the valuable role that anidulafungin can play in the management of these life threatening infections and is an important medicine for critically ill patients."

Invasive candidiasis is a serious fungal infection caused by the yeast Candida, an important cause of complication and death in patients with a compromised immune system.

About Ecalta®

- Results from a double-blind pivotal clinical trial of 245 patients with invasive candidasis (mostly candidaemia) showed anidulafungin to achieve superior global success rate compared to fluconazole at the end of IV therapy (primary endpoint at two weeks): 75.6% vs 60.2%, p=0.01 (95% Confidence Interval for the difference 3.9 - 27.0%).2

- Anidulafungin is given intravenously through infusion once-a-day - 200mg on day one, followed by 100mg daily thereafter. Duration of treatment should be based on the patient's clinical response. In general, antifungal medicines for candidaemia should be given for at least 14 days after the last positive culture.3

- Anidulafungin requires no dose adjustment in special populations (age, gender, race, renal or hepatic insufficiency, or HIV status).3

- Anidulafungin does not have any known drug interactions, although in vitro studies do not exclude in vivo interactions.

- Anidulafungin has demonstrated to be generally well tolerated with a comparable safety profile to fluconazole.2

- In the pivotal clinical study, adverse events leading to discontinuation of the study drug occurred in 27 patients receiving fluconazole and 15 receiving anidulafungin (p=0.02).2

About Pfizer

Pfizer Inc, the world's largest research-based pharmaceutical company, discovers, develops, manufactures and markets prescription medicines in 11 therapeutic areas including oncology, cardiovascular, pain, neuroscience and infectious diseases, including HIV/AIDS. Pfizer is also the world's largest animal health company.

Pfizer Inc employs approximately 90,000 colleagues worldwide, all of whom are devoted to working for a healthier world. Pfizer conducts more biomedical research than any other organisation, and has 12,000 professionals working in six major R&D sites worldwide, including Sandwich in Kent. Pfizer's annual UK R&D investment is more than £550 million - more than £10 million a week.

In the UK, Pfizer has its European R&D headquarters at Sandwich and its UK business headquarters in Surrey, and is the major supplier of medicines to the NHS.

http://www.pfizer.co.uk

References

1. Anidulafungin 100mg powder and solvent for concentrate for solution for infusion (Ecalta®) No.(465/08). Scottish Medicines Consortium. 10 October 2008.

2. Reboli AC, Rotstein C, Pappas PG, Chapman SW, Kett DH, Kumar D, Betts R, Wible M, Goldstein BP, Schranz J, Krause DS, Walsh TJ; Anidulafungin Study Group. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med. 2007;356(24):2472-82.

3. Ecalta® Summary of Product Characteristics. http://www.medicines.org.uk. Last updated 20th September 2007.

Pfizer Inc.