Bayer Submits New Drug Application for LCS-16 for Pregnancy Prevention for up to Five Years
WHIPPANY, N.J., Nov. 20, 2015 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for LCS-16, an investigational hormonal intrauterine device (IUD) for pregnancy protection for up to five years.
The submission is based on data from the Phase III clinical trials which included 574 nulliparous and 878 parous women from North America and several European countries. The primary endpoint of the Phase III clinical trial program was contraceptive efficacy assessed by the Pearl Index
"As a global leader in Women's Healthcare, Bayer is committed to the continuous advancement of our portfolio of contraceptive methods to help meet the needs of a broad range of women," said Dario Mirski, M.D., vice president and head of U.S. medical affairs at Bayer. "With this submission, we hope to offer women an additional long-acting reversible contraception for up to five years."
LCS-16 is an investigational agent and is not approved by the U.S. FDA, the European Medicines Agency (EMA) or other health authorities. An application for marketing authorization for LCS-16 was submitted to the EMA in November 2015 for approval of the same indication in the European Union.
About LCS-16
LCS-16 is an investigational intrauterine device (IUD) containing 19.5 mg of a progestin hormone called levonorgestrel. The NDA has been submitted to the FDA to seek approval for use to prevent pregnancy for up to five years.
Bayer: Science for a Better Life
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their lives. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2014, the Group employed around 119,000 people and had sales of EUR 42.2 billion. Capital expenditures amounted to EUR 2.5 billion, R&D expenses to EUR 3.6 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.com.
Bayer® and the Bayer Cross® are registered trademarks of Bayer.
Forward-Looking Statements
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 www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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SOURCE Bayer HealthCare Pharmaceuticals
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