Bayer's Endometriosis Drug Visanne (Dienogest) Approved in China

Yesterday, Bayer announced that its new drug for the treatment of endometriosis, Visanne (dienogest tablets), has been approved for marketing in China. It is reported that this is the first progestin specifically developed for the treatment of endometriosis worldwide, and it received its initial marketing authorization in 2009. Studies have shown that Visanne can effectively alleviate pain, reduce lesion size, and lower the postoperative recurrence rate. The drug is generally well-tolerated by patients and can be used safely over the long term.

Endometriosis is a common gynecological disorder in women, characterized by the implantation of viable endometrial cells outside the uterine cavity. These ectopic tissues undergo cyclic bleeding and shedding in synchrony with the menstrual cycle. Common clinical manifestations include menstrual irregularities, anemia, dysmenorrhea, dyspareunia, and rectal tenesmus or pain. In severe cases, the condition may impair ovarian function and disrupt the pelvic environment, leading to pelvic organ adhesions and fallopian tube distortion, which can subsequently result in infertility.

Endometriosis predominantly affects women of reproductive age. According to the 2014 report by the World Endometriosis Society, there are approximately 200 million patients with endometriosis worldwide. Clinical data analysis in China indicates that among the 290 million women of childbearing age, the prevalence of endometriosis ranges from 10% to 15%.

For such patients, the goals of both pharmacological and surgical treatments are to reduce and eliminate lesions, alleviate and control pain, treat infertility and promote fertility, and prevent and reduce recurrence. Currently, surgery offers favorable therapeutic outcomes; however, endometriosis is associated with a high rate of recurrence. Therefore, postoperative pharmacological therapy is particularly important, especially for patients suffering from pain, primarily aiming to relieve pain through medication.

Generally, pharmacological treatment for endometriosis involves hormonal therapy, including oral contraceptives, gonadotropin-releasing hormone agonists (GnRH-a), progesterone receptor antagonists, and gestrinone. Among these, GnRH-a is currently a commonly used medication for endometriosis, with proven efficacy in the short-term relief of endometriosis-associated symptoms. However, safety concerns, such as adverse effects including decreased bone mineral density and hot flashes, limit its long-term use.

Visanne is a tablet containing 2 mg of dienogest. Studies have demonstrated that this medication does not present the aforementioned safety concerns associated with GnRH agonists (GnRH-a). In a clinical study involving 252 patients with endometriosis, using GnRH-a as an active control, results showed that Visanne was comparable to GnRH-a in efficacy for pain management.

Another global study involving 198 patients with endometriosis confirmed that dienogest was significantly superior to placebo in alleviating pain. In clinical trials, Visanne was generally well tolerated. Notably, the most common adverse reactions associated with this medication included headache and breast discomfort, which tended to gradually resolve with prolonged treatment.

Professor Zhou Yingfang, Deputy Director of the Department of Obstetrics and Gynecology at Peking University First Hospital, stated, “Visanne is an important therapeutic option for endometriosis and has been the only new treatment available for long-term use in these patients over the years.” Currently, Visanne has received marketing authorization in more than 90 countries, with a cumulative annual user base exceeding 15 million female patients worldwide.

Source: WuXi AppTec