Marketing authorisation acquired for first and only transdermal contraceptive patch in UK

Gedeon Richter UK Ltd has announced that it has become marketing authorisation holder (MAH) for Evra, a once-weekly contraception for women of fertile age and the only transdermal contraceptive patch licensed in the UK.

According to the company, Evra is over 99% effective at preventing pregnancy. Gideon Richter acquired the rights from Janssen Pharmaceutical NV.

“The addition of a patch to our existing contraceptive delivery methods, such as oral contraceptives, emergency contraceptives, and our intra-uterine system, enables us to proudly offer a wide selection of family planning solutions to women in the UK,” said Tamas Neubauer, managing director for the UK and Ireland of Gedeon Richter.

“The acquisition emphasises our commitment to providing healthcare professionals and women with greater choice in contraception. As one of only a few companies in the world to offer a comprehensive gynaecological portfolio, we have years of experience in women’s healthcare and won’t rest until women can.”

The hormonal patch, which can be worn discreetly, is a square patch applied to the lower abdomen, buttocks, upper torso or outer upper arm and the application is once-weekly. Each patch is worn for seven days before being replaced for three weeks. The fourth week is treatment free.

“Collaborative decision-making should help women choose a method that fits their individual circumstances, reducing the risk of dissatisfaction, misuse, or non-use,” said Dr Ali Kubba, senior consultant in contraception and reproductive health at Guys’ and St Thomas’ Hospital, London.

“It is vitally important that companies recognise the importance of contraceptive choice and bring a broad range of effective products to the market which make a difference to women’s health and fit with their differing lifestyles.”

The safety and tolerability of the contraceptive patch has been analysed in a comparative study, involving 812 participants with the Evra patch and 605 with oral contraceptives.

Evra was also studied in a pooled analysis, involving 3,330 participants with the contraceptive patch for up to 13 treatment cycles.