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International Approvals: Aromasin, IPM Wound Gel, Risperdal Consta
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International Approvals: Aromasin, IPM Wound Gel,
Risperdal Consta
Yael Waknine
Sept. 19, 2005 — The European Commission has approved exemestane tablets for the treatment
of estrogen receptor –positive invasive early breast cancer after two to three years of initial adjuvant
tamoxifen therapy in postmenopausal women; the Panamanian Ministry of Health has approved a
hyaluronic acid–based gel for the management of exuding or debrided wounds; and the Italian
Ministry of Health has approved a long -acting risperidone injection for the treatment of
schizophrenia.
Exemestane (Aromasin) for Use After Tamoxifen in Breast Cancer in Europe
On Sept. 13, the European mutual recognition variation procedure was completed for exemestane
(Aromasin tablets, made by Pfizer, Inc.), allowing its use for the treatment of estrogen receptor –
positive invasive early breast cancer after two to three years of initial adjuvant tamoxifen therapy in
postmenopausal women.
Approval of the new indication was based on data from the phase 3 Intergroup Exemestane Study
(IES) in 4,742 women. The study results showed that use of the drug was associated with a
significant improvement in disease-free survival for a median of 30.6 months.
In the study, women who switched to exemestane after two or three years of tamoxifen therapy
experienced a 32% reduction in the risk of local/metastatic recurrence, contralateral breast cancer,
or death compared with those receiving five years of tamoxifen therapy (unadjusted hazard ratio,
0.68; 95% confidence interval [CI], 0.56 - 0.82; P < .001).
The absolute benefit of exemestane in terms of disease-free survival at three years was 4.7% (95%
CI, 2.6 - 6.8). Overall survival was similar between groups.
Exemestane was linked to a higher incidence of arthralgia and diarrhea, while gynecologic
symptoms, vaginal bleeding, and muscle cramps were more common with tamoxifen. Exemestane
was associated with a lower rate of thromboembolic events (1.3% vs 2.4%; P = .007).
Exemestane tablets were previously approved in 1999 by the European Commission for the
treatment of advanced breast cancer after prior anti-estrogen therapy and by the U.S. Food and
Drug Administration for the treatment of advanced breast cancer in postmenopausal women whose
disease has progressed after tamoxifen therapy.
http://www.medscape.com/viewarticle/513057?src=mp
10/4/2005
International Approvals: Aromasin, IPM Wound Gel, Risperdal Consta
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Hyaluronic Acid Gel (IPM Wound Gel) for Healing Ulcers and Debrided Wounds in Panama
On Sept. 14, the Panamanian Ministry of Health approved a hyaluronic acid (HA) –based gel (IPM
Wound Gel, made by LAM Pharmaceutical Corp. and distributed by aQva Pharmaceuticals, Inc.) for
the management of exuding (such as leg, pressure, and diabetic ulcers) and debrided wounds. The
product is also available without a prescription for use on minor abrasions and cuts.
The clear and odorless aqueous gel is composed mainly of sodium hyaluronate, a purified
derivative salt of HA obtained from avian sources. Unlike other glycosaminoglycans such as
chondroitin or chondroitin sulfate, HA is not immunogenic.
According to a company news release, wounds containing high concentrations of HA heal rapidly
with little scarring. The effect is thought to be due to the molecule's ability to serve as a
transportation system between the epidermal and dermal skin layers, allowing increased efficiency
in the process of wound healing (inflammatory cell migration, fibroblast cell migration, cytokine
migration, and epithelial cell migration).
The approval was based on the results of a study in 27 patients with 53 nonhealing ulcers of at
least one month's duration (mean, 25.34 weeks) showing that treatment was well tolerated and
89% of ulcers were healed at four months.
The HA-based gel was approved by the U.S. Food and Drug Administration and the Ecuadorian
Ministry of Health in April 2002 and March 2005, respectively.
Long -Acting Risperidone Injection (Risperdal Consta) for Schizophrenia in Italy
On Sept. 15, Italy's Ministry of Health approved a long -acting injectable formulation of risperidone
(Risperdal Consta, made by Alkermes, Inc., and marketed by Janssen -Cilag S.p.A., a subsidiary of
Johnson & Johnson) for the treatment of schizophrenia.
The formulation consists of risperidone encapsulated in microspheres made of a biodegradable
polymer and suspended in a water -based solution. It is administered by intramuscular injection on a
biweekly rather than daily basis.
Risperidone long -acting injection was approved by the U.S. Food and Drug Administration on Oct.
29, 2003, and is currently available in more than 70 countries worldwide.
Reviewed by Gary D. Vogin, MD
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10/4/2005
International Approvals: Aromasin, IPM Wound Gel, Risperdal Consta
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Medscape News CME: Risperidone May Be Better Than Haloperidol for First-Episode Psychosis
Yael Waknine is a freelance writer for Medscape.
Medscape Medical News 2005. © 2005 Medscape
Medscape Medical News is edited by Deborah Flapan, assistant managing editor of news at
Medscape. Send press releases and comments to [email protected] .
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10/4/2005