Pfizer Inc., one of the world's premier innovative biopharmaceutical companies, announced that its injectable contraceptive, Sayana Press (medroxyprogesterone acetate) is now available to women in the United Kingdom for administration by self-injection.
This follows the recent approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of an update to the Sayana Press label, adding the option for self-injection by women when considered appropriate by a healthcare professional (HCP).
Sayana Press is the first injectable contraceptive in the UK available for administration via self-injection. This new method of administration is also approved or pending local approval in additional European Union (EU) markets (Austria, Belgium, Hungary, Ireland, Netherlands). Pfizer will continue its efforts to help bring this updated label to more countries across the globe, with an initial focus on those in the developing world – such as in Burkina Faso, Senegal and Uganda – where data show unmet need and demand for injectable contraceptivesiv. Sayana Press is not yet approved for self- injection outside of the EU.
“With this revised label, following consent from a healthcare professional and with proper training, UK women will now have the opportunity to administer Sayana Press outside of a clinical setting,” said Dr. Salomon Azoulay, senior vice president and chief medical officer, Pfizer Global Established Pharma Business.
“This is an exciting milestone for women in the United Kingdom and potentially, in countries around the world, who might prefer this method of contraception and mode of administration.”
Sayana Press combines a long-acting, reversible, contraceptive with an all-in-one prefilled, single-use, non-reusable Uniject injection system, eliminating the need to prepare a needle and syringe. Approved for use by the MHRA in 2011, the contraceptive is indicated for the prevention of pregnancy. Each subcutaneous injection prevents ovulation and provides contraception for at least 13 weeks (+/- one week).
Injectable contraceptives are a widely-used family planning method, particularly among women in developing countries. They are discreet, eliminate the need for a daily pill regimen and, for some women living in remote areas, they can alleviate the deterrent of having to frequently travel long distances to get to a clinic. Accordingly, experts have identified the need for a contraceptive method that can be administered in low-resource, non-clinic settings.
In November 2014, Pfizer Inc., the Bill & Melinda Gates Foundation and the Children’s Investment Fund Foundation (CIFF) entered into a partnership to help broaden access to Sayana Press for women most in need in 69 of the world’s poorest countries. Through this collaboration, Sayana Press is being sold for US $1 per dose to qualified purchasers, who help enable the poorest women in these countries to have access to the contraceptive at reduced or no cost. The agreement is supported by a consortium of private sector donors and aid organisations, which include PATH, United Kingdom’s Department for International Development (DFID), the United Nations Population Fund (UNFPA) and the United States Agency for International Development (USAID).
“Helping to broaden access to Sayana Press is a key priority for Pfizer,” said John Young, president, Pfizer Global Established Pharma Business.
“Through the tremendous efforts and ongoing collaboration with our Partners, we have already made great progress in bringing Sayana Press to thousands of women living in sub-Saharan Africa. We hope to continue the great momentum achieved, enabling us to further help address the specific family planning needs of women in the developing world.”
In July 2014, this same consortium of public and private organisations piloted efforts to help make Sayana Press available for the first time in four countries in sub-Saharan Africa. Through June 2015, more than 170,600 Sayana Press units have been distributed to health facilities across Burkina Faso, Niger, Senegal and Uganda. In addition, over 6,000 health care providers were trained on Sayana Press administration.
Sayana Press is approved by regulatory authorities in the European Union and in a number of countries across the globe, including Bangladesh, Burkina Faso, Kenya, Niger, Nigeria, Senegal and Uganda. Additional regulatory submissions are being pursued.