(The following press release from Bayer was received by e-mail. It was not
confirmed by the sender.)
Not intended for U.S. and UK media
Bayer receives approval for new long-term contraceptive Skyla™ in the U.S.
New low dose levonorgestrel-releasing intrauterine system (IUS) / Longterm
contraception for up to three years
Berlin, January 10, 2013 - Bayer HealthCare has received approval from the
U.S. Food and Drug Administration (FDA) for its new low dose
levonorgestrel-releasing intrauterine system (IUS) called
Skyla™ in the U.S.. The new IUS is placed in the uterus for the prevention
of pregnancy for up to three years.
"The approval of Skyla in the U.S. highlights Bayer’s continued commitment
to drive innovation and empower women with a variety of birth control
options at different reproductive stages of their lives," said Kemal Malik,
M.D., Member of the Bayer HealthCare Executive Committee and Head of Global
Development. "We are pleased to provide women who are seeking contraception
with a new and effective option to consider with their healthcare providers
in the U.S.."
Skyla is a small, flexible plastic T-shaped device containing 13.5mg of a
hormone called levonorgestrel. The size of the Skyla T-body is 28mm x 30mm,
and its placement tube has a diameter of 3.8mm. It slowly releases a low
dose of levonorgestrel locally in the uterus and therefore only small
amounts of the hormone enter the bloodstream.
Compared to oral contraceptives the new IUS is a reliable contraceptive
option for women that do not want to take a pill every day. It also offers
rapid return to a woman’s usual level of fertility after removal.
In December 2012 Bayer HealthCare successfully concluded the European
registration procedure for this new low dose levonorgestrel-releasing
intrauterine system. Bayer HealthCare plans to market the new IUS under the
brandname "Jaydess" in the EU.
About the Clinical Development Program for Skyla
The approval of Skyla is supported by data from a Phase 3 trial of 2,884
women aged 18-35. There were 1,432 women who received Skyla, of which 39
percent (556) had not yet had a child. The study was a multicenter,
multi-national randomized open-label study conducted in 11 countries in
Europe, Latin America, the U.S. and Canada.
The Pearl Index was the primary efficacy endpoint used to assess
contraceptive reliability. The data showed that Skyla is more than 99
percent effective in preventing pregnancy.
Skyla was generally well tolerated, with no unexpected adverse events (AE)
reported. Low incidences of ectopic pregnancy, pelvic inflammatory disease
(PID), expulsion of the device from the uterus and uterine perforation were
The results of this study have been presented at 68th Meeting of the
American Society for Reproductive Medicine in San Diego, California, in
To learn more about contraception, please visit:
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields
of health care, agriculture and high-tech materials. Bayer HealthCare, a
subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one
of the world’s leading, innovative companies in the healthcare and medical
products industry and is based in Leverkusen, Germany. The company combines
the global activities of the Animal Health, Consumer Care, Medical Care and
Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop,
manufacture and market products that will improve human and animal health
worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec
31, 2011) and is represented in more than 100 countries. More information
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Find more information at http://www.bayerpharma.com.
This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management.
Various known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results, financial
situation, development or performance of the company and the estimates
given here. These factors include those discussed in Bayer’s public reports
which are available on the Bayer website at http://www.bayer.com. The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments.
This press release is available here:
Yours BayNews Editorial Team
51368 Leverkusen, Germany
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