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Effect of weight on efficacy of Emergency Contraceptives...

Paris - July 24th, 2014

Effect of weight on efficacy of Emergency Contraceptives: Conclusion of the referral initiated by the EMA

The European Medicines Agency (EMA) has now published its conclusions after a thorough review of data available from all manufacturers, with regards to the effect of increasing weight on the efficacy of Emergency Contraceptives (EC) (see EMA website)

The effect of a woman’s weight on levonorgestrel (LNG) efficacy was first identified in 2011 in the context of clinical trials conducted by HRA Pharma in a contemporary population of Western women, including overweight and obese. As a result, HRA Pharma performed further analyses in 2012 confirming these first findings, and felt it was its duty to alert Health Authorities, in the interest of women concerned about unintended pregnancy. The evaluation of these data by health authorities in 2013 was then followed up at the start of 2014, by an examination of all data available to all EC manufacturers (article 31 procedure) by the EMA, leading to the conclusions presented in their recent announcement.

HRA Pharma acknowledges the decision of the EMA who considered that the signal observed on levonorgestrel in our studies was not confirmed in other historical trials, conducted primarily in Asia and Africa, and to which HRA Pharma had no access. Thus, EMA concluded that benefit-risk balance of emergency contraceptives remains favorable, and that they should be used regardless of weight or BMI. Nevertheless, EMA has decided to harmonize the labelling of all emergency contraceptive products to include all available data.

HRA's core mission in this process has always been to allow women on a global basis to have as much information as possible, to enable them to make informed decisions about emergency contraception. With obesity increasing at an alarming rate globally, it is a public health imperative to understand the impact of weight on drug effectiveness. We are proud that our diligence in communicating our data to the health authorities has led to an open debate and discussion, ultimately resulting in harmonized information ?for healthcare providers and women who need EC.

We will continue to provide regulatory authorities, healthcare professionals, and patients with the most current, accurate and up to date research on emergency contraception.

Media Contacts Julian Barlow - PR for HRA Pharma D - +44 (0) 1628 857979 M - +44 (0) 7747 852070 Email – julian@barlowcomms.co.uk
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