International Approvals: Seasonale, Pergoveris, Tambocor

Yael Waknine

August 06, 2007

August 6, 2007 — Health Canada has approved an extended-cycle levonorgestrel/ethinyl estradiol 0.15 mg/0.03 mg birth control regimen that reduces the annual incidence of menstrual periods to 4; the European Commission has approved a follitropin alfa/lutropin alfa combination injection for the stimulation of follicular development in women who are infertile because of severe gonadotropin deficiencies; and Japan has approved flecainide tablets for the prophylaxis of paroxysmal atrial fibrillation/flutter.

Extended-Cycle Birth Control Regimen ( Seasonale) in Canada

On July 4, Health Canada approved an extended-cycle birth control regimen consisting of 84 levonorgestrel/ethinyl estradiol 0.15 mg/0.03 mg tablets and 7 placebo tablets (Seasonale, Duramed Pharmaceuticals, Inc [a subsidiary of Barr Pharmaceuticals, Inc] and marketed by Paladin Labs, Inc).

The regimen is intended to reduce the incidence of menstrual periods from 13 to 4 per year.

According to a company news release, it is the first extended-cycle regimen to be approved in Canada and is expected to be available in the fourth quarter of 2007. The levonorgestrel/ethinyl estradiol 0.15 mg/0.03 mg birth control regimen previously was approved by the US Food and Drug Administration (FDA) in October 2003. A generic formulation (Quasense, Watson Laboratories, Inc) was also cleared by the FDA in September 2006.

Combination LH/FSH Injection (Pergoveris) for the Treatment of Female Infertility in EU

On June 29, the European Commission approved a biotechnology product (Pergoveris, Merck Serono SA) for the stimulation of follicular development in women who are infertile as a result of severe luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiencies. It was initially given a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in April 2007.

The primary effect of LH is to increase estradiol secretion by the follicles, the growth of which is stimulated by FSH. According to a company news release, the product is the first to combine the 2 recombinant gonadotropins (r-hFSH [follitropin alfa, 150 IU] and r-hLH [lutropin alfa, 75IU]) in a single subcutaneous injection.

The CHMP notes that in clinical trials, patients eligible for therapy were defined by an endogenous serum LH level less than 1.2 IU/L. Ovarian cysts, headache, and mild to severe injection site reactions (pain, erythema, bruising, swelling, and/or irritation at the site of injection) were the most commonly experienced adverse events.

The company notes that the approval applies to all 27 countries of the European Union, Iceland, Liechtenstein, and Norway. Product launches in the EU are expected to begin during the third quarter of 2007.

Follitropin alfa/lutropin alfa 150-IU/75-IU injection has not been approved by the US Food and Drug Administration.

Flecainide (Tambocor) to Prevent Paroxysmal Atrial Fibrillation/Flutter in Japan

On June 26, the Japanese Ministry of Health, Labor, and Welfare (MHLW) approved a new indication for flecainide acetate 50- and 100-mg tablets (Tambocor, Eisai Company, Ltd), allowing their use for the prophylaxis of paroxysmal atrial fibrillation/flutter (PAF).

"In Japan, it has been reported that the number of patients with paroxysmal atrial fibrillation/flutter is estimated to be greater than 1 million, and also the incidence increases in parallel with age," the company says in a news release, adding that the need for treatment is expected to continue to increase with population size.

Flecainide previously was approved by the MHLW for the treatment of ventricular tachyarrhythmias, and by the US Food and Drug Administration for use in patients without structural heart disease to prevent paroxysmal supraventricular tachycardias, PAF, and documented ventricular arrhythmias.

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