FDA Approvals: Cancidas, Enbrel, Enbrel Prefilled Syringe, Monistat 1 Combination Pack

Yael Waknine

October 14, 2004

Oct. 14, 2004 — The U.S. Food and Drug Administration (FDA) has approved caspofungin acetate for the empiric treatment of presumed fungal infections in the setting of febrile neutropenia, etanercept for inducing major clinical response in rheumatoid arthritis, a once-weekly formulation of etanercept, and a treatment regimen allowing daytime use of miconazole nitrate insert and cream.

Caspofungin (Cancidas) for Empiric Antifungal Treatment in Febrile Neutropenia

On Oct. 12, the FDA approved caspofungin acetate (Cancidas, made by Merck & Co.) for the once-daily empiric treatment of presumed fungal infection in febrile neutropenic patients. Caspofungin is the first in a class of antifungals called echinocandins that inhibit synthesis of an integral component of the fungal cell wall, ß (1,3)-D-glucan.

The approval was based on the results of a multicenter, double-blind trial involving 1,095 febrile neutropenic patients that showed caspofungin to be similarly effective to amphotericin B overall (33.9% vs 33.7%) and in terms of seven-day survival (92.6% vs 89.2%), prevention of infection breakthrough for one week posttreatment (94.8% vs 95.5%), completion of therapy (89.7% vs 85.5%), resolution of fever during period of neutropenia (41.2% vs 41.4%), and successful treatment of baseline infection.

Caspofungin therapy was associated with a significantly lower incidence of clinical and laboratory adverse events (54.4% vs 69.3%) and infusion-related adverse events (35.1% vs 51.6%) compared with amphotericin B. Adverse events included fever (17%), chills (13.8%), rash (6.2%), headache (4.3%), hypokalemia (3.7%), and vomiting/nausea (3.5%).

Treatment with caspofungin was also associated with a significantly lower incidence of nephrotoxicity in patients with moderately impaired renal function compared with amphotericin B (2.6% vs 11.5%). Discontinuation of treatment due to adverse events and toxicity/inefficacy occurred at significantly lower rates with use of caspofungin (5.0% vs 8.0%, 10.3% vs 14.5% respectively) compared with amphotericin B.

Caspofungin was previously approved for the treatment of invasive aspergillosis, first-line treatment of candidemia and other Candida infections (intra-abdominal abscesses, peritonitis, and pleural space infections), and esophageal candidiasis.

Etanercept (Enbrel) to Induce Major Clinical Response in RA

On Sept 28, the FDA approved a new indication for etanercept (Enbrel, made by Immunex Corp., a division of Amgen, and marketed by Wyeth Pharmaceuticals, a division of Wyeth), allowing its use in inducing a major clinical response in patients with rheumatoid arthritis (RA). Etanercept is the first biologic to receive this indication, which represents the maintenance of high-level symptom control over a sustained period of time.

Major clinical response is defined as achieving an American College of Rheumatology 70 response (ACR 70) for six consecutive months. ACR 70 is the highest level of sign and symptom control in this evaluation system and measures improvements in RA disease activity, including joint swelling and tenderness, pain, level of disability, and overall patient and physician assessment.

The label for etanercept has also been updated to include radiographic data from an open-label study showing that 55% of patients with early, active RA taking etanercept therapy experienced no progression of joint damage at five years.

Etanercept is now approved to reduce RA signs and symptoms, induce major clinical response, improve physical function, and inhibit progressive structural damage in moderately to severely active RA. It is also indicated in the treatment of psoriatic arthritis, ankylosing spondylitis, chronic moderate to severe plaque psoriasis in adults aged 18 years and older, and moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs.

50 mg/mL Etanercept (Enbrel) Prefilled Syringe for Once-Weekly Dosing

On Sept. 28, the FDA approved a 50 mg/mL etanercept prefilled syringe (Enbrel, made by Immunex Corp., a division of Amgen, and marketed by Wyeth Pharmaceuticals, a division of Wyeth) as the recommended dosing formulation for treatment in all approved adult indications.

The prefilled syringe eliminates the need to mix the drug prior to injection and allows most patients requiring etanercept to take once-weekly injections of 50 mg instead of biweekly 25 mg injections.

The approval was based on the results of a study showing the 50 mg/mL etanercept prefilled syringe to be biologically equivalent to two 25 mg etanercept vials. The 25 mg formulation will remain available for patients with juvenile rheumatoid arthritis and those preferring that dosing method.

Etanercept is now approved to reduce RA signs and symptoms, induce major clinical response, improve physical function, and inhibit progressive structural damage in moderately to severely active RA. It is also indicated in the treatment of psoriatic arthritis, ankylosing spondylitis, chronic moderate to severe plaque psoriasis in adults aged 18 years and older, and moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs.

Miconazole Nitrate Insert and Cream (Monistat 1 Combination Pack) for Daytime Use

On Oct. 1, the FDA approved a new dosing regimen for 1,200 mg miconazole nitrate insert and 2% miconazole nitrate cream (Monistat 1 Combination Pack, made by Personal Products Co.), allowing daytime administration of the product in addition to the currently proscribed bedtime administration.

Miconazole is indicated in the treatment of vulvovaginal candidiasis.

Reviewed by Gary D. Vogin, MD

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