The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on two high-profile medicines, one on Takeda’s dengue fever Vaccine, another is an allograft of Atara Biotherapeutics CAR-T Therapy for the treatment of post-transplant EBV-positive lymphoproliferative disease.
dengue
Dengue feverIt is an acute infectious disease caused by the dengue virus, which is transmitted to humans by mosquitoes (Aedes aegypti and Aedes albopictus). And it is divided into four serotypes, I, II, III, and IV, and each type has the ability to infect and cause disease. The prevalence of individual serotypes varies across geographies, countries, regions, seasons and times. Once a patient is infected with a certain type of dengue virus, they will have lifelong immunity to that type of virus, and only a short-term immunity to other types of dengue virus, and they may be reinfected with other serotype viruses. . Clinically repeated infection with different types of dengue virus may cause different degrees of host response, ranging from mild or insignificant symptoms to typical dengue fever with fever and rash, or warning signs such as lethargy, restlessness, and liver enlargement , and even severe dengue fever that can lead to severe bleeding or severe organ damage.
Takeda TAK-003
Takeda’s quadrivalent dengue vaccine (TAK-003) is an attenuated vaccine against dengue serotype II virus. According to Phase 2 clinical trial data in children and adolescents, TAK-003 successfully induced an immune response in subjects with all four dengue serotypes that persisted for a total of 48 months after vaccination and was found to be a Safe and well tolerated.
Another key is the Phase 3 pivotal trial in Dengue Fever (TIDES) involving 20,000 patients aged 4-16 years. The results showed that the primary evaluation index, namely, vaccine-induced immune response (vaccine efficacy, referred to as vaccine efficacy), was achieved in virologically-confirmed dengue (VCD) patients followed for 12 months. At the 18-month follow-up period, all secondary measures were met, including vaccine efficacy in hospitalized patients with dengue fever, and vaccine efficacy in seronegative and positive patients. Efficacy results vary depending on the serotype of the patient. The trial results also demonstrated that TAK-003 was generally well tolerated, with no serious safety risks observed so far.
CHMP gives positive opinion
TAK-003 is recommended for prophylaxis in the European Union and dengue endemic countries participating in the EU-M4all program in patients 4 years of age and older suffering from dengue disease caused by any dengue virus serotype.
The CHMP has a positive opinion on TAK-003, based primarily on the results of a Phase 3 clinical trial in more than 20,000 children and adolescents in eight dengue-endemic countries, following 4.5 years of efficacy and safety data.
The vaccine is expected to receive marketing authorization in Europe in the next few months, followed by the review results of the Latin American and Asian regulatory authorities.
Post-transplant Epstein-Barr virus-positive lymphoproliferative disorder (EBV+ PTLD)
EBV+ PTLD (Epstein-Barr virus positive post-transplant lymphoproliferative disease) is a rare, acute and potentially fatal hematological malignancy that can occur in patients undergoing transplantation because their T-cell activity is impaired by the use of immunosuppressive drugs. It affects patients who have received a solid organ transplant (SOT) or an allogeneic hematopoietic stem cell transplant (HCT). Among patients with EBV+ PTLD who had failed standard therapy with rituximab ± chemotherapy, median survival on HCT and SOT was only 0.7 months and 4.1 months, respectively, representing a significant unmet medical need due to the lack of effective therapy.
About Ebvallo (tabelecleucel) and approval by the competent authority
Ebvallo is an allogeneic, EBV-specific T-cell immunotherapy that targets and destroys in an HLA-restricted manner EBV infected cells.
Ebvallo (tabelecleucel) has been granted Breakthrough Therapy Designation by the US FDA for the treatment of rituximab-refractory EBV-associated lymphoproliferative disorder (LPD), and concurrently received Orphan Drug Designation.
In the European EMA, Ebvallo (tabelecleucel) received PRIME designation for the treatment of patients with EBV+ PTLD who have failed rituximab in allogeneic hematopoietic stem cell transplantation (HCT); the drug also received orphan drug designation.
The basis for the approval by the competent authority mainly comes from the results of the ALLELE Phase III pivotal trial. Therefore, the trial just ended in June this year, and the final public data has not yet been published, which needs to be corroborated by future literature. The drug is expected to receive EU approval in the fourth quarter.
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