Schering’s new low-dose contraceptive approved in Netherlands
pharmafile | August 19, 2005 | News story | Sales and Marketing |
Yasminelle, a new low-dose oral contraceptive from Schering has received its first European marketing approval in the Netherlands.
The country is the reference state for the mutual recognition of the product across the EU, where the company expects to launch the drug in the coming months.
Schering's Yasmin is the world's biggest-selling contraceptive pill, earning the company E256 million in the first half of 2005, up 34% from the same period last year.
But concerns about the long-term effects of oral contraceptives mean manufacturers are developing lower-dose versions of its drugs, such as Yasminelle.
Contraceptive pills are associated with increased risk of breast cancer, hypertension and blood clots, but are also thought to lower the risk of ovarian cancer and endometrial cancer.
Yasminelle contains 20 micrograms of ethinyl estradiol and three milligrams of drospirenone in a 21-day active pill intake regimen. This is the same combination as Yasmin, the only difference being a 20 microgram dose of ethinyl estradiol rather than 30 micrograms.
"Yasminelle adds to our rich product portfolio that has helped us become the global leader in contraception. Yasminelle will build upon the success of Yasmin, which is the number one oral contraceptive worldwide," said Philip Smits, head of gynaecology and andrology at Schering AG.
"We are well on track with developing the Yasmin family. In addition, we are currently awaiting US approval for YAZTM, a drospirenone-containing oral contraceptive with a new 24-day active pill regimen," he said.
Schering said the success of Yasmin is based on the novel progestin drospirenone. The drug is unique in exhibiting antimineralocorticoid and antiandrogenic properties, unlike any other progestin available in oral contraceptives.
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