International Approvals: Optaflu, Altabax, Laresse

Yael Waknine

June 18, 2007

June 18, 2007 — The European Commission has approved a cell-culture-derived influenza vaccine and retapamulin 1% ointment for the treatment of impetigo and infected small lacerations, abrasions, or sutured wounds. The Australian Therapeutic Goods Administration has approved a dermal filler made from nonbacterial, nonanimal sources and free of cross-linking chemicals for the nonpermanent correction of facial wrinkles and lines.

Cell-Culture-Derived Influenza Vaccine (Optaflu) in EU

On June 13, the European Commission approved an influenza vaccine (Optaflu, Novartis Pharmaceuticals Corp) for intramuscular use in all 27 member states of the European Union (EU), Iceland, and Norway.

The vaccine is the first to be made using the company’s proprietary cell line, rather than chicken eggs, to provide antigen components, thereby enabling flexible and more rapid manufacturing start-up in the event of a potential pandemic threat.

Because most circulating viral strains are unable to replicate in chicken eggs, use of the cell line offers the advantage of increased production. Moreover, elimination of potential viral adaptation caused by replication in eggs can enable vaccine antigens to more closely resemble the wild-type viral surface, potentially translating into a better immunogenic and efficacy response, the company said.

The approval was based on data from a clinical development program (n > 3,400), showing that the cell-culture-derived vaccine was comparable to conventional egg-based vaccines in stimulating immune response and tolerability. Benefits of the new vaccine include its lack of additives, such as antibiotics and thimerosol, and its ability to be used in individuals with allergies to eggs or egg products.

According to a news release, the company expects the vaccine to be available in Germany and Austria for the 2007/2008 flu season, and then in other countries for the 2008/2009 season. Submission for its approval by the US Food and Drug Administration is anticipated in 2008.

Retapamulin 1% Ointment ( Altabax) for the Treatment of Impetigo in EU

On June 4, the European Commission approved retapamulin 1% ointment (Altabax, GlaxoSmithKline) for use in all 29 participating states of the European Union (EU). Retapamulin is indicated for the topical treatment of impetigo and infected small lacerations, abrasions, or sutured wounds most commonly caused by Staphylococcus aureus and Streptococcus pyogenes in patients aged 9 months and older.

The first in a new class of antibacterial drugs called pleuromutilins, retapamulin binds to a site on the 50S subunit of the bacterial ribosome to inhibit protein synthesis. It is applied twice daily for a 5-day period, in contrast to previously approved topical products, which are applied as often as 3 times daily for 12 days.

Retapamulin "demonstrates no clinically relevant target-specific cross-resistance to currently used antibacterials, possesses excellent in vitro activity against bacteria that have become resistant to other classes of antibacterials, and appears to have a low potential for the development of resistance due to its unique mode of action," the company noted in a news release.

The approval followed a positive recommendation from the European Medicines Evaluation Agency in March 2007, which was primarily based on data from a placebo-controlled phase 3 trial of 210 adult and pediatric patients with impetigo, 82% of whom had culture-proven pathogens. Results showed that retapamulin was linked to a significantly increased clinical success rate (85.6% vs 52.1%), defined as a response requiring no further antibacterial treatment. Microbacterial success rates were likewise significantly greater in the retapamulin group than in the placebo group(91.2% vs 50.9%).

These findings were supported by data from a second pivotal study, showing that retapamulin was an effective therapy for impetigo, compared with fusidic acid, a drug not available in the United States. Additional phase 3 clinical trials compared the safety and efficacy of retapamulin with oral cephalexin for infected abrasions, minor cuts, and wounds in patients aged 9 months and older.

Application-site irritation was the most commonly reported adverse event and occurred in about 1% of 2150 patients.

Retapamulin ointment is available in 5-, 10-, and 15-g tubes for application to the affected area (up to 100 cm2 total area in adults or 2% total body surface area in children aged 9 months or older) twice daily for 5 days. In the event of sensitization or severe local irritation, retapamulin should be wiped off and appropriate alternative therapy instituted.

Retapamulin ointment was approved by the US Food and Drug Administration in April 2007 for the treatment of impetigo caused by susceptible strains of S aureus or S pyogenes in patients aged 9 months and older.

CMC/PEO Temporary Dermal Filler (Laresse) for Wrinkles/Lines in Australia

On June 6, the Australian Therapeutic Goods Administration approved an injectable dermal filler (Laresse, FzioMed, Inc) for the temporary correction of wrinkles and lines caused by sun exposure, aging, and other factors.

Unlike dermal fillers composed of hyaluronic acid or collagen, this ultra-smooth, colorless, long-lasting gel is made with pure absorbable polymers carboxymethylcellulose (CMC) and polyethylene oxide (PEO), which provide a high level of stability without the use of chemical cross-linking. The lack of animal, bacterial, or chemical byproducts reduces the product’s immunogenic potential, the company said.

The CME/PEO dermal filler was previously approved for use in the European Union.

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