CHMP says yes to Esmya for uterine fibroids symptoms and Vepacel pre-pandemic flu vaccine
This article was originally published in Scrip
The European Medicines Agency's scientific committee, the CHMP, has issued a positive opinion for PregLem France's Esmya (ulipristal acetate), for pre-operative treatment of symptoms of uterine fibroids in adult women, and Baxter's A/H5N1 pre-pandemic flu vaccine, Vepacel.
Esmya is a pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Treatment is limited to three months because there are no data available yet on longer treatment durations or on repeat courses of treatment. It is a selective progesterone receptor modulator characterised by a tissue-specific partial progesterone antagonist effect. It acts by depriving uterine fibroids of growth stimulation due to progesterone and its benefits include reduction of fibroid-related bleeding, anaemia and fibroid size.
Vepacel is a non-adjuvanted vaccine, which prompts an immune response against the H5N1 antigen. It is able to mount an appropriate immune response in individuals from the age of 18 years onwards that are immunologically naïve against the vaccine strain, including immunocompromised and chronically ill subjects, said the committee.