U.S. FDA Approves Natazia, a New Oral Contraceptive for the Prevention of Pregnancy

Author: Bayer HealthCare Pharmaceuticals Inc.
Published: 2010/05/08
Topic: FDA News and Approvals - Publications List

Page Content: Synopsis - Introduction - Main

Synopsis: Introducing the first and only oral contraceptive to bring estradiol valerate together with dienogest in a new dosing regimen.

Introduction

Main Item

Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Natazia (estradiol valerate and estradiol valerate/dienogest) tablets for the prevention of pregnancy. Natazia has not been evaluated in women with a BMI of greater than 30 kg/m(2). Natazia is the first and only oral contraceptive that contains an estrogen called estradiol valerate and a progestin called dienogest. Estradiol valerate is a synthetic estrogen that is converted to estradiol in a woman's body. Natazia is expected to be available in the summer.

Until today, all marketed combination oral contraceptives (COCs) contained ethinyl estradiol. With the FDA approval of Natazia, Bayer HealthCare Pharmaceuticals becomes the first company to launch estradiol valerate together with the progestin, dienogest.

"Every woman's body reacts differently to hormones, so it is important that they have a choice in birth control options," said Anita Nelson, MD, professor of obstetrics and gynecology at the Harbor-UCLA Medical Center, Torrance, California. "Natazia may be a good option for women to consider when making a decision with their healthcare provider about which birth control option is right for them."

Women using COCs, including Natazia, should be strongly advised not to smoke. Smoking increases the risk of serious cardiovascular side effects from COC use. The risk increases with age and the number of cigarettes, especially in women over 35 years old.

Natazia is taken once a day. The dosing regimen consists of pills with varying doses of estradiol valerate, and estradiol valerate in combination with dienogest, for specific days of the 28-day cycle.

"We are very pleased that the FDA has approved Natazia as an effective option for the prevention of pregnancy, as it further demonstrates the commitment of Bayer Women's Healthcare to meeting the individual needs of women," said Stefan Oelrich, Vice President and General Manager, Women's Health Care, Bayer HealthCare Pharmaceuticals.

Natazia should not be used in women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal genital bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors (benign or malignant) or liver disease, or who are pregnant.

The use of Natazia is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, hypertension, ruptured ovarian cyst and uterine leiomyoma. The excess risk of thromboembolic events is highest during the first year of use of COC.

Patients should be counseled that OCs do not protect against HIV infection and other sexually transmitted diseases.

About Natazia's Clinical Trials

Overall Efficacy and Safety

The safety and efficacy of Natazia as an oral contraceptive was evaluated in two multi-center phase 3 clinical trials in North America and Europe involving 1,867 women. Natazia was found to be effective as a hormonal contraceptive in both studies.

The Pearl Index (PI) was the primary measure for assessing contraceptive reliability for two of the studies and found Natazia to be highly effective in preventing pregnancy. The PI calculation was based on criteria established by the FDA (pregnancies that occurred in women aged 18-35 years during cycles 1-13 (including pregnancies 7 days post-treatment).

The most common treatment-emergent adverse reactions (greater than or equal to 2%) were headache (including migraines) (13.2%), metrorrhagia and irregular menstruation (8.0%), breast pain, discomfort or tenderness (6.6%), nausea or vomiting (6.5%), acne (3.9%), and increased weight (2.8%).

For full prescribing information, please visit www.natazia.com or call 1.888.84.BAYER.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

This news 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.

BAYER and the Bayer Cross are registered trademarks of Bayer. Natazia is a trademark of Bayer.