International Approvals: Follistim, Tracleer, Prograf

Yael Waknine

April 18, 2005

April 18, 2005 — The Japanese Ministry of Health, Labor, and Welfare has approved use of recombinant follicle-stimulating hormone injection for controlled ovarian hyperstimulation in assisted reproductive technologies; bosentan tablets for the treatment of all forms of pulmonary arterial hypertension in patients with World Health Organization class III or IV symptoms; and a new indication for tacrolimus capsules, allowing their use in the treatment of rheumatoid arthritis in patients who respond insufficiently to current therapies.

Recombinant FSH (Follistim) for Use in Assisted Reproduction in Japan

On April 14, the Japanese Ministry of Health, Labor, and Welfare approved the use of recombinant follicle-stimulating hormone injection (Follistim, made by Organon, Inc, the human healthcare business unit of Akzo Nobel) for controlled ovarian hyperstimulation in assisted reproductive technologies. It is the first such product approved for use in Japan.

In contrast to follicle-stimulating hormone derived from the urine of menopausal women (urinary FSH), the newly approved recombinant follicle-stimulating hormone injection is administered subcutaneously rather than by intramuscular injection, and its use requires fewer doses.

According to a company news release, use of the recombinant product also yields an increased quantity of eggs for collection, increased egg quality, and an increased quantity of embryos for transfer and storage, all leading to increased pregnancy rates compared with urinary FSH stimulation.

The recombinant hormone product was approved in 1995 for use in the European Union (Puregon, marketed by Organon affiliates), and in the U.S. (Follistim, made by OrganonUSA, Inc). A cartridge format (Follistim AQ) was approved for use in the U.S. in March 2004 to increase dosing precision and flexibility.

Bosentan (Tracleer) for Pulmonary Arterial Hypertension in Japan

On April 11, the Japanese Ministry of Health, Labor, and Welfare approved bosentan tablets (Tracleer, made by Actelion, Ltd) for the treatment of all forms of pulmonary arterial hypertension (PAH) in patients with World Health Organization class III or IV symptoms to improve exercise ability and decrease the rate of clinical worsening.

According to a company news release, approximately 11% of patients receiving bosentan for PAH in clinical trials experienced abnormal but reversible enzyme elevations. Monthly monitoring of liver function is therefore recommended.

Due to the risk of birth defects associated with its use, bosentan should not be used in pregnant women or in those of child-bearing age who do not use a reliable method of contraception.

The oral dual endothelin receptor antagonist was previously approved for use in the U.S., Canada, the European Union, Australia, Switzerland, Israel, Hong Kong, Malaysia, Singapore, Brazil, and other countries worldwide.

Tacrolimus (Prograf) for Rheumatoid Arthritis in Japan

On April 11, the Japanese Ministry of Health, Labor, and Welfare approved a new indication for tacrolimus anhydrate 0.5-mg and 1.0-mg capsules (Prograf, made by Astellas Pharma, Inc), allowing their use in the treatment of rheumatoid arthritis in patients who respond insufficiently to current therapies.

Tacrolimus capsules were previously approved in Japan for the prophylaxis of organ rejection in transplant patients and for the treatment of generalized myasthenia gravis.

Tacrolimus capsules and injection (Prograf, made by Fujisawa Healthcare, Inc) are approved in the U.S. for the prophylaxis of organ rejection in patients receiving allogenic liver or kidney transplantation.

Reviewed by Gary D. Vogin, MD

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