The European Commission has approved the marketing of Esmya (PregLem France SAS) in the preoperative treatment of moderate to severe symptoms of uterine fibroids. A revolutionary advance, according to Professor Hervé Fernandez, obstetrician-gynecologist at the University Hospital of Kremlin-Bicetre.
European Commission approves Esmya in the preoperative treatment of uterine fibroids. A revolution?
The fibroids are noncancerous tumors, composed of fibrous tissue very hard and very dense. They grow from the uterine muscle (myometrium) and fibrous tissue of the uterus. Can measure a few millimeters to several tens of centimeters, the fibroids are very common. An estimated 20 to 40% of women between 30 and 45 have presented or will present uterine fibroids. This is the tumor most common solid female. Most often discrete, most fibroids are detected by chance during a pelvic exam. But nearly 25% require treatment.
Current treatments for uterine fibroids. Several treatment options are currently available:
– A medication may be used. It is based on the suppression of estrogen production, resulting in atrophy of the fibroid. The catch: the usefulness of this type of treatment is usually transient and has many side effects similar to those of menopause, such as headaches, hot flashes, vaginal dryness, bone decalcification or fatigue. Furthermore, this treatment does not prevent the costly fibroid to recover a few months after stopping treatment.
– The surgical option is by far the most traumatic. There are two types of intervention, depending on the size of the tumor: the myomectomy , which involves removing the tumor when it is not too big, or hysterectomy (removal of the uterus) Among women whose fibroid is too large, multiple or for those who want no more children.
– Recently, of other approaches have been developed, more conservative. These are arterial embolization of uterine fibroids, which involves injecting microspheres into the arteries feeding the fibroids, causing them to necrosis; of myolysis , which relies on the destruction of the tumor using a electric current of focused ultrasound therapy guided by MRI, a new alternative of emitting a beam of high intensity ultrasound that will heat and destroy targeted tissue, non-invasively.
Surgical techniques generally require a preoperative preparation, which aims to reduce the size of fibroids and reduce bleeding. Used in this case the same drugs as those proposed in first intention.
Esmya, a newcomer to the preoperative treatment of fibroids
In late February, the European Commission has authorized the marketing of Esmya ®, a drug indicated for the preoperative treatment of fibroids. Its active ingredient, ulipristal acetate belongs to the family of SPRM (selective progesterone receptor modulator). It has reduced bleeding in more than 90% of patients in less than a week, depending on the results of two clinical phase 3 (final phase before the application for authorization on the market – AMM), which results were published in the New England Journal of Medicine. The drug has also reduced from 36 to 42% tumor volume.
Compared with GnRH agonists, the standard treatment, Esmya therefore allows much faster control of bleeding (7 days on average against 21 days in women receiving leuprolide acetate), a smaller reduction in tumor volume (- 53 % with leuprolide acetate), but longer lasting. Its management also results in fewer side effects (hot flashes in 10% of women against 40% with leuprolide acetate). And, best of all, this is a simple pill to swallow when leuprolide acetate is administered by intramuscular injection.
A revolutionary treatment that could avoid surgery?
For Professor Hervé Fernandez, obstetrician-gynecologist at the University Hospital of Kremlin-Bicetre, the commercialization of Esmya ® is ” the only true revolution for 25 years in the treatment of fibroids . ” The marketing authorization application filed by the pharmaceutical company that manufactured the tablet based on the ” facilitation of operating time , “says this specialist Doctissimo. ” Studies show that taking the medication for three months allowed women to be quiet for 6 to 9 months , “said he. This will also lead a clinical trial in France for several months, to see if taking this medicine makes unnecessary surgery in women with symptomatic fibroids.