International Approvals: Rotarix, Hycamtin, Pulmicort HFA

Yael Waknine

March 06, 2006

March 6, 2006 — The European Commission has approved a live attenuated rotavirus vaccine for the prevention of rotavirus gastroenteritis in infants, and a new indication for topotecan HCl intravenous infusion, allowing its use in the treatment of refractory small cell lung cancer. Finland's National Agency for Medicines has approved a chlorofluorocarbon-free pressured metered-dose inhaler formulation of budesonide for the maintenance treatment of asthma in adults and children.


Rotavirus Vaccine (Rotarix) for Infants in EU

On February 27, the European Commission approved a live attenuated rotavirus vaccine (Rotarix, made by GlaxoSmithKline) for use in infants aged 6 weeks and older to prevent rotavirus gastroenteritis (RVGE).

Due to the high incidence of RVGE in infants aged 6 to 24 months, the vaccine has been designed to fit in with existing vaccination schedules (eg, oral polio vaccine) and to confer early protection against multiple rotavirus strains. The 2-dose vaccine is administered orally at approximately 2 and 4 months of age.

The approval was based on data from studies showing the vaccine to be 78% to 90% effective for preventing severe rotavirus diarrhea during the first season. Its overall efficacy rate for preventing rotavirus diarrhea during this period ranged from 63% to 73%. The vaccine's protective effects were maintained for both end points during the second season (84% and 73%, respectively).

According to a company news release, the vaccine was not linked to an increased risk for intestinal intussusception.

The product was previously approved for use 33 countries worldwide, including 16 Latin American countries, the Philippines, and Singapore. It is currently under consideration for approval by the US Food and Drug Administration.


Topotecan HCl (Hycamtin IV) for Refractory Small-Cell Lung Cancer in EU

On February 1, the European Commission (EC) approved a new indication for topotecan HCl powder for infusion solution (Hycamtin, made by GlaxoSmithKline), allowing its use in the treatment of patients with relapsed small cell lung cancer (SCLC) for whom retreatment with the first-line regimen is not appropriate.

According to a company news release, topotecan is the first drug to be approved in Europe that is specifically indicated for the treatment of relapsed SCLC.

The approval was primarily based on data from three phase 3 trials. Results of the first study showed topotecan to be similarly effective to a 3-drug regimen (cyclophosphamide, doxorubicin, and vincristine [CAV]) with respect to improving median overall survival in patients with sensitive SCLC (25.0 vs 24.7 weeks; P = .80).

According to the news release, topotecan appeared to provide greater symptom improvement than CAV and was not associated with neurotoxicity. Patients receiving topotecan also experienced significant improvement in breathing difficulties and anorexia, thereby improving their quality of life.

A second trial comparing oral and intravenous formulations of topotecan found both to be similarly well tolerated and effective in this patient population (median overall survival, 33.0 vs 35.0 weeks; hazard ratio, 0.98).

In the third trial, addition of oral topotecan to best supportive care (BSC) was associated with a significant increase in median overall survival compared with BSC alone (25.9 vs 13.9 weeks; P = .01).

Topotecan intravenous injection was previously approved by the EC for the treatment of relapsed ovarian cancer. It is approved by the US Food and Drug Administration for both indications.


CFC-Free Budesonide MDI (Pulmicort HFA) for Asthma in Finland

On February 9, Finland's National Agency for Medicines approved a new pressurized metered-dose inhaler (pMDI) formulation for budesonide (Pulmicort HFA, made by AstraZeneca) for the maintenance treatment of asthma in adults and children. It is available in 100- and 200-µg strengths.

In accordance with the Montreal Protocol, the formulation based on hydrofluoroalkanes (HFA) will replace the chlorofluorocarbon (CFC) pMDI formulation that has been marketed in the country since December 2001. CFCs are known to deplete the ozone layer.

According to a company news release, additional approvals for the CFC-free budesonide formulation are being sought in other European and non-European markets. The product has not yet been approved for use by the US Food and Drug Administration.

Reviewed by Gary D. Vogin, MD

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