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Monday 17 July 2006

International Approvals: NuvaRing, MabThera, Gemzar

By: Yael Waknine

Australia's Therapeutic Goods Administration has approved a once-monthly etonogestrel/ethinyl estradiol vaginal ring for contraceptive use in women; the European Commission has approved a new indication for rituximab injection, allowing its use in combination with methotrexate to reduce signs and symptoms of moderately to severely active refractory rheumatoid arthritis in adults; and Japan's Ministry of Health, Labor, and Welfare has approved a new indication for gemcitabine HCl injection, allowing its use for the treatment of biliary tract cancer.

Etonogestrel/Ethinyl Estradiol Vaginal Ring (NuvaRing) for Contraception in Australia

On July 7, Australia's Therapeutic Goods Administration approved an etonogestrel/ethinyl estradiol vaginal ring (NuvaRing, made by Organon, a unit of Akza Nobel) for once-monthly contraceptive use in women. According to a company news release, it will be available in Australia in early 2007.

The contraceptive vaginal ring (made by Organon USA, Inc) was approved for this indication by the US Food and Drug Administration in October 2001.

Rituximab (MabThera) for Rheumatoid Arthritis in EU

On July 11, the European Commission (EC) approved a new indication for rituximab injection (MabThera, made by Roche and marketed by Genentech, Inc, and Biogen Idec, Inc, as Rituxan in the United States), allowing its use in combination with methotrexate to reduce signs and symptoms of moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or are intolerant to current treatment options, including one or more tumor necrosis factor-alpha (TNF-alpha) inhibitor therapies.

According to a company news release, approximately up to 40% of RA patients do not respond to currently available biologic therapies. Rituximab is the first treatment for RA that selectively targets CD20+ B cells to provide lasting improvement in this subgroup of patients who are considered the most difficult to treat, with benefits observed after a single course of therapy.

The approval was based on a priority review of data from 3 randomized, double-blind, placebo-controlled trials in patients with active RA.

Results of the pivotal phase 3 (REFLEX) trial in 520 patients showed that the addition of a single treatment course of 2 rituximab infusions (1000 mg on days 1 and 15) to a stable dose of methotrexate yielded significant improvements in joint pain (51% vs 18%), inflammation (27% vs 5%), and physical function (12% vs 1%) at 24 weeks compared with methotrexate alone, as determined using the American College of Rheumatology (ACR) 20, 50, and 70 response rates.

The most commonly observed adverse events in rituximab-treated patients were infusion reactions and infections. Infusion reactions were serious in less than 1% of patients, and the incidence of serious infection was 2% (vs placebo, 1%). The overall rate of serious adverse events was 7% in patients treated with rituximab vs 10% of those who received placebo.

Rituximab therapy was not associated with a significant change in average immunoglobulin levels. No increases were observed in the risks for hematologic malignancies, demyelinating events, or opportunistic infections, including tuberculosis.

According to the news release, in recently presented 1-year data, no long-term safety concerns were identified in more than 800 rituximab-treated patients followed for 1 year or more. Moreover, rituximab therapy significantly inhibited the structural damage to joints caused by RA in patients who have had an inadequate response to other TNF-inhibitor therapies.

Moreover, patients receiving additional courses between 6 and 12 months after initial treatment experienced further improvement in symptoms, and a doubling of remission rates from 6% to 13% after the second course of treatment.

Rituximab was approved for this indication by the US Food and Drug Administration (FDA) in February 2006. The agent was previously approved by the FDA and the EC for the treatment of relapsed or refractory low-grade or follicular CD20+ B-cell non-Hodgkin lymphoma. It is also indicated for the

first-line treatment of diffuse large CD20+ B-cell non-Hodgkin lymphoma, in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other anthracycline-based chemotherapy regimens.

Rituximab's potential benefit as add-on therapy in patients with RA who have an inadequate response to methotrexate is currently being studied in a large pivotal phase 3 study consisting of 3 trials. Other potential indications include other immune diseases, including systemic lupus erythematosus and multiple sclerosis.

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