October 2022 batch of recommendations from EMA's CHMP

The European Medicines Agency (EMA) today announced recommendations made by its human medicines committee (CHMP) following its October 2022 meeting. These will now be forwarded for a final decision from the European Commission, which usually comes within two to three months.

The CHMP recommended granting a marketing authorization for Dengue Tetravalent Vaccine (Live, Attenuated), from Japanese pharma major Takeda (TYO: 4502), 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. Dengue tetravalent vaccine prevents fever, severe disease and hospitalization caused by any of the four serotypes of the dengue virus. This vaccine received an EMA recommendation under the EU Medicines for all program, 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 European Union, under the trade name Qdenga

The committee adopted a positive opinion for a marketing authorization under exceptional circumstances for the advanced therapy medicinal product (ATMP) Ebvallo (tabelecleucel), from US biotech Atara Biotherapeutics (Nasdaq: ATRA) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease. This ATMP is intended for adult and pediatric 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.