10 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its October 2022 meeting.
The CHMP recommended granting a marketing authorisation for Dengue Tetravalent Vaccine (Live, Attenuated) Takeda for the prevention of dengue virus serotypes 1, 2, 3 and 4 in people from four years of age. Dengue is a mosquito-borne tropical disease caused by the dengue virus, leading to mild flu-like symptoms in most people. However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage. The global estimated death rate is 20,000 to 25,000 per year, primarily in children. Dengue tetravalent vaccine prevents fever, severe disease and hospitalisation caused by any of the four serotypes of the dengue virus. This vaccine received an EMA recommendation under the EU Medicines for all (EU-M4All) programme, a mechanism that allows the CHMP to assess medicines that are intended for use in low- and middle-income countries outside of the European Union (EU). Simultaneously, the vaccine has also received a positive opinion for use in the EU, under the trade name Qdenga. See more information in the news announcement in the grid below.
The committee adopted a positive opinion for a marketing authorisation under exceptional circumstances for the advanced therapy medicinal product (ATMP) Ebvallo* (tabelecleucel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease. This ATMP is intended for adult and paediatric patients who experience a serious complication following solid organ transplantation or bone marrow transplantation. Ebvallo was supported through EMA’s PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients’ unmet medical needs. See more information in the news announcement in the grid below.
Eladynos (abaloparatide) received a positive opinion for the treatment of osteoporosis in postmenopausal women at increased risk of fractures.
The committee recommended granting a marketing authorisation under exceptional circumstances for Livmarli* (maralixibat chloride) intended for the treatment of cholestatic pruritus (itching) in adult and paediatric patients from two months of age with Alagille syndrome, an inherited condition in which bile builds up in the liver.
The CHMP gave a positive opinion for Locametz (gozetotide), which is intended for the diagnosis of prostate cancer.
The committee adopted a positive opinion for Pluvicto (lutetium (177Lu) vipivotide tetraxetan) for the treatment of prostate cancer.
Spevigo (spesolimab) received a positive opinion for a conditional marketing authorisation for the treatment of flares in adult patients with generalised pustular psoriasis, a skin disorder that consists of pus spots surrounded by areas of red skin.
The committee adopted positive opinions for three generic medicines:
Dimethyl fumarate Teva (dimethyl fumarate), indicated for the treatment of adult and paediatric patients aged 13 years and older with multiple sclerosis, a chronic disease affecting the central nervous system.
Pemetrexed Baxter (pemetrexed) for the treatment of malignant pleural mesothelioma, a rare cancer of the lining around the lungs, and non-small cell lung cancer.
Plerixafor Accord (plerixafor) for the treatment of adults and children with lymphoma and multiple myeloma, two types of white blood cells cancers.
Recommendations on extensions of therapeutic indication for four medicines
The committee recommended four extensions of indication for medicines that are already authorised in the EU: Brukinsa, Libtayo, Lyumjev and Xydalba.
Withdrawals of initial applications
The applications for marketing authorisation for biosimilar medicines Tuznue and Hervelous were withdrawn by the applicant during the re-examination of the negative opinions that the committee adopted at its May 2022 meeting. These medicines were intended for the treatment of certain forms of breast cancer and gastric (stomach) cancer. A question-and-answer document on the withdrawals is available in the grid below.
The committee recommended converting the conditional marketing authorisation of the COVID-19 vaccine Vaxzevria to a standard marketing authorisation.
Agenda and minutes
The agenda of the October 2022 CHMP meeting is published on EMA’s website. Minutes of the September 2022 CHMP meeting will be published in the coming weeks.
Key figures from the October 2022 CHMP meeting are represented in the graphic below.
*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA’s Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.