Option contains new, synthetic version of naturally occurring oestrogen
Gedeon Richter has announced the availability of Drovelis (E4/DRSP) as a combined oral contraceptive across the UK.
The decision to prescribe it takes 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 to be made available by the NHS in England.
The Marketing Authorisation is based on outcomes from two phase 3 randomised control trials in Europe, which enrolled 1,553 women aged between 18 and 50 years. The secondary for both trials was to assess the contraceptive efficacy, bleeding patterns and general safety in women involved. The current known safety profile for E4/DRSP is aligned with that known for combined oral contraceptives.
“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,” reflected Dr Diana Mansour, consultant in community gynaecology and reproductive health care, Newcastle upon Tyne.
“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,” added 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.”