International Approvals: Cubicin, BeneFIX, Aricept

September 17, 2007

September 17, 2007 — The European Commission has approved daptomycin intravenous infusion for the treatment of right-sided infective endocarditis and bacteremia caused by Staphylococcus aureus; the European Medicines Agency has approved new products intended to streamline the reconstitution process for recombinant factor IX intravenous injection; and the Japanese Ministry of Health, Labor, and Welfare has approved donepezil HCl 10-mg tablets for the treatment of severe Alzheimer's disease.

Daptomycin Injection ( Cubicin) for RIE and Certain Bacteremias in EU

On September 5, the European Commission approved 2 new indications for daptomycin intravenous infusion (Cubicin, Cubist Pharmaceuticals, Inc), allowing its use for the treatment of right-sided infective endocarditis (RIE), caused by Staphylococcus aureus, and S aureus bacteremia (SAB) when associated with RIE or complicated skin/soft tissue infections (cSSSi).

"In the UK alone, more than 15,000 patients are estimated to contract SAB infections every year," the company says in a news release. "If not quickly and effectively treated, up to one-third of these patients may die from the infections. With growing resistance to current treatments, these types of infections are becoming an increasingly serious public health challenge."

The approval was based on data from a phase 3 clinical trial, showing that daptomycin was equally effective against both methicillin-susceptible and methicillin-resistant S aureus (MSSA and MRSA, respectively).

Daptomycin therapy also met primary endpoints for noninferiority compared with traditional dual therapy (semisynthetic penicillin plus initial gentamycin for MSSA infections; vancomycin plus initial gentamycin for MRSA infections).

"While the current standard of treatment often requires combination therapies, [daptomycin] is a simpler approach to Gram-positive infections as a once-daily monotherapy that requires no routine therapeutic drug monitoring," the company notes.

The recommended dose of daptomycin for RIE and SAB caused by MSSA or MRSA is 6 mg/kg, administered for more than a 30-minute period by intravenous infusion in 0.9% sodium chloride once every 24 hours for a minimum of 2 to 6 weeks.

Daptomycin previously was approved for these indications by the US Food and Drug Administration in August 2006 and by the Taiwanese Department of Health and the South Korean Food and Drug Administration in August 2007. It also is approved in these countries for the treatment of cSSSIs caused by susceptible isolates of designated gram-positive microorganisms.

New Products Streamline Preparation of Factor IX Product (BeneFIX) in EU

On August 20, the European Medicines Agency approved new enhancements for recombinant coagulation factor IX intravenous injection (nonacog alfa; BeneFIX, Wyeth Pharmaceuticals, Inc) that are intended to streamline the reconstitution process.

These benefits include a 2000-IU dosage strength vial, to reduce the number of vials required for a dose, and a prefilled 5-mL diluent syringe for use with all dosage strengths that provides increased convenience and may reduce the overall infusion volume.

"Each of these new features was designed to enable BeneFIX patients to spend less time preparing their factor product, to prepare it more safely and to have additional time for themselves," says Gary L. Stiles, MD, executive vice president and chief medical officer, Wyeth Pharmaceuticals, in a company news release.

Coagulation factor IX (recombinant) is indicated for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency).

Donepezil HCl 10-mg Tablets Bevacizumab (Aricept) Severe AD in Japan

On August 22, the Japanese Ministry of Health, Labor, and Welfare approved a new 10-mg dose and corresponding indication for donepezil HCl (Aricept, Eisai Company, Ltd), that allows its use for the treatment of severe Alzheimer's disease (AD).

According to a company news release, the approval was based on data from clinical trials conducted abroad and in Japan.

Results from the multicenter, randomized, double-blind, placebo-controlled Japanese study (n = ~300) showed that whereas use of 5- or 10-mg/day donepezil significantly improved cognitive function, use of the 10-mg/day dose also significantly improved global functioning vs placebo at 6 months.

Adverse events most commonly reported in the higher-dose group were gastrointestinal in nature and mild to moderate in severity.

The recommended initial dose for patients with mild to moderate AD is 3 mg donepezil once daily; this dose may be increased to 5 mg daily after 1 or 2 weeks. Those with severe AD should start with a dose of 5 mg/day and uptitrate it to 10 mg/day after 4 weeks.

Donepezil 3- and 5-mg tablets previously were approved in Japan for the treatment of mild to moderate AD. The 10-mg dose of donepezil and its use for severe AD were approved by the US Food and Drug Administration in October 2006.

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