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 The other is an allogeneic CAR-T therapy from Atara Biotherapeutics for the treatment of EBV-positive lymphoproliferative disease after transplantation.
Takeda Announces Positive Results from Pivotal Trials in Autoimmune Disease (Geneline Online International Edition)
dengue
Dengue fever 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 particular type of dengue virus, they will have lifelong immunity to that type of virus, and only short-term immunity to other types of dengue virus, and they can be re-infected with viruses other serotype. Clinically repeated infection with different strains of dengue virus can cause varying 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 swelling of the liver, and even severe dengue fever which can lead to severe bleeding or serious 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 was able to induce an immune response in subjects with all four dengue serotypes that lasted for a total of 48 months after vaccination and was found to be Safe and is well tolerated.
Another key is the pivotal Phase 3 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. In the 18-month follow-up period, all secondary measures were completed, including vaccine efficacy in hospitalized patients with dengue fever, and vaccine efficacy in seronegative and positive patients. Efficacy results vary depending on the patient’s serotype. The results of the trial also showed that TAK-003 was generally well tolerated, and no serious safety risks have been observed so far.
CHMP gives a 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 results of a review by Latin American and Asian regulatory authorities.
Epstein-Barr virus-positive post-transplant 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 transplant patients due to the use of immunosuppressive drugs impairing their cell activity T. It affects patients who have had 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 lack of effective therapy .
About Ebvallo (tabelecleucel) and approval from the competent authority
Ebvallo is an allogeneic, EBV-specific T-cell immunotherapy that targets and destroys EBV-infected cells in an HLA-restricted manner.
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.
At 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 approval by the competent authority comes mainly from the results of the pivotal ALLELE Phase III trial. Therefore, the trial ended in June this year, and the final public data has not yet been published, which needs to be confirmed by future literature. The drug is expected to be approved by the EU in the fourth quarter.
Extended reading: Open a new page of autoimmune therapy! CAR-T has been used successfully in lupus erythematosus
Addresses:
https://www.takeda.com/newsroom/newsreleases/2022/Positive-CHMP-Opinion-Recommending-Approval-of-Dengue-vaccine/
https://investors.atarabio.com/news-events/press-releases/detail/291/chmp-recommends-approval-of-atara-biotherapeutics
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