Gedeon Richter announces the availability of the first and only oral contraception containing a new, synthetic version of a naturally occurring oestrogen in the UK
London, United Kingdom, 18 October 2022 – Gedeon Richter UK Ltd. (“Gedeon Richter”) today announced the availability of Drovelis®▼(14.2mg estetrol [E4] plus 3mg drospirenone [DRSP]) as a combined oral contraceptive in the UK. The decision to prescribe E4/DRSP should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism. This announcement comes approximately a year after the Medicines and Healthcare products Regulatory Agency (MHRA) granted a UK licence for E4/DRSP.
The announcement means E4/DRSP is the first contraceptive tablet using this new combination of hormones (E4, an oestrogen, plus DRSP, a progestogen), to be made available by the NHS in England.
“Over three million women in the UK choose to take ‘the Pill’ as their main method of contraception. As healthcare professionals, we support increasing a patient’s contraceptive choice. For the first time, we are now able to prescribe a combined hormonal contraceptive tablet containing synthetic E4, plus the well-known progestogen DRSP.” Dr Diana Mansour, Consultant in Community Gynaecology and Reproductive Health Care, Newcastle upon Tyne.
The Marketing Authorisation is based on outcomes from two Phase 3 randomised control trials, the pivotal E4 FREEDOM trial (conducted in Europe/Russia) which enrolled 1,553 women aged between 18 and 50 years, and the supportive Study MIT-Es0001-C302 (conducted in the US/Canada) which enrolled 1,864 women aged between 16 and 50 years. The primary endpoint for both trials was 13-cycle Pearl Index (PI) (number of pregnancies per 100 woman-years of exposure) for women aged 18 to 35 years and 16 to 35 years, respectively. The PI from E4 FREEDOM (Europe/Russia) for E4/DRSP in at-risk cycles was 0.47 (95% CI: 0.15-1.11).3 The PI from Study MIT-Es0001-C302 (US/Canada) reported more pregnancies compared to E4 FREEDOM, with an at-risk cycle PI of 2.65 (95% CI: 1.73, 3.88).
The secondary endpoint for both the E4 FREEDOM (Europe/Russia) trial and Study MIT-Es0001-C302 (US/Canada) was to assess the contraceptive efficacy, bleeding patterns and general safety in women aged 18-50 and 16-50 years of age respectively.
The current known safety profile for E4/DRSP, investigated in the E4 FREEDOM trial and Study MIT-Es0001-C302, is aligned with that known for combined oral contraceptives. The most common adverse events (which may affect up to 1 in 10 people) are metrorrhagia (irregular bleeding between periods) (4.3%), headache (3.2%), acne (3.2%), vaginal haemorrhage (vaginal bleeding) (2.7%) and dysmenorrhoea (painful periods) (2.4%).
“We have years of experience supporting women with their reproductive health and we are pleased to add this new combined oral contraceptive to our gynaecological portfolio,” said David Jordan, Medical Director UK and Ireland, Gedeon Richter. “Choice plays an essential role when selecting a suitable contraceptive. We pride ourselves on being able to provide multiple options, across a number of delivery methods, and now including a combined hormonal tablet.”
▼Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Gedeon Richter (UK) Ltd on +44 (0)207 604 8806 or by email to email@example.com.