Takeda’s Takhzyro fares well in pediatric hereditary angioedema study

Takeda (NYSE:TAK) has announced that in the open-label Phase 3 SPRING study, children aged 2 to <12 had 94.8% fewer hereditary angioedema (HAE) attacks during treatment with Takhzyro (lanadelumab-flyo) over 52 weeks compared to baseline.

The Osaka, Japan–based company plans on presenting the data at the European Academy of Allergy and Clinical

The SPRING study also had positive, clinically meaningful results in children under 6. Children in that age bracket currently have no approved long-term prophylaxis treatment (LTP).

The SPRING study’s findings align with prior studies focused on adults and adolescents.

Takeda aims to submit global regulatory filings later this year.

The primary objective of the SPRING study was to investigate the safety and pharmacokinetics of Takhzyro in patients aged 2 to <12 years with HAE. The prevention of HAE attacks was a secondary outcome measure.

“HAE is a rare condition where unpredi…

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Takeda wins approval to distribute Novavax’s COVID-19 vaccine in Japan

Takeda (NYSE:TAK) has announced that it has won manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid, a novel COVID-19 vaccine.

Nuvaxovid (NVX-CoV2373) was initially developed by Novavax (Nasdaq:NVAX).

The approval covers the use of the vaccine as both a primary and booster immunization in adults at least 18 years old.

Get the full story from our sister site, Drug Discovery & Development. 

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Takeda wins approval to distribute Novavax’s COVID-19 vaccine in Japan

Takeda (NYSE:TAK) has announced that it has won manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid, a novel COVID-19 vaccine.

Nuvaxovid (NVX-CoV2373) was initially developed by Novavax (Nasdaq:NVAX).

The approval covers the use of the vaccine as both a primary and booster immunization in adults at least 18 years old.

Nuvaxovid is a recombinant protein-based vaccine.

Sanofi (Nasdaq:SNY) and GSK (NYSE:GSK) are also jointly developing a similar COVID-19 vaccine. Sanofi and GSK also announced their intent to file international regulatory submissions for their recombinant protein-based COVID-19 vaccine candidate.

Osaka, Japan–based Takeda won regulatory approval after submitting efficacy and safety data from a Phase 1/2 study in Japan and data from two pivotal Phase 3 trials in the UK, U.S. and Mexico. The company also submitted data from Phase 1/2 studies in Australia and Phase 2 data…

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Takeda’s Takhzyro hit primary endpoints in pediatric hereditary angioedema trial 

The plasma kallikrein inhibitor Takhzyro (lanadelumab) from Takeda (TSE:4502/NYSE:TAK) met its objectives in a Phase 3 study focused on hereditary angioedema (HAE) in children aged 2 to 12 in an open-label Phase 3 study.

In the SHP643-301 multicenter, open-label study, Takhzyro also had a safety profile similar to that observed in clinical trials focused on patients 12 years old and older.

HAE involves recurring episodes of severe (angioedema) in various body parts, including the abdomen, limbs, face, intestinal tract, genitals, hands and throat.

HAE attacks involving the airways can be potentially life-threatening.

Takhzyro recently won approval in Japan as a prophylaxis against acute attacks of HAE.

“We are encouraged by these results, as each objective met instills further confidence in the potential to bring a treatment option to this vulnerable population,” said Ashley Yegin, global medical unit head, HAE, global medical affairs at Tak…

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Takeda wins Japanese approval for Takhzyro as a prophylaxis against acute attacks of hereditary angioedema

Takeda (TSE:4502/NYSE:TAK) has received approval from Japanese regulatory authorities for subcutaneous injection of the monoclonal antibody Takhzyro (lanadelumab) as a prophylaxis against acute attacks of hereditary angioedema (HAE) in individuals at least 12 years old.

HAE involves recurring episodes of severe (angioedema) in various body parts such as the abdomen, limbs, face, intestinal tract, genitals, hands and throat.

Attacks affecting the airways can be potentially life-threatening.

The drug’s approval in Japan was based on data from the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study and the Phase 3 HELP Study Open-label Extension (OLE).

Takeda also submitted results from a Phase 3 study evaluating the efficacy and safety of Takhzyro in Japanese patients. In that study, 41.7% of the Takhzyro recipients did not have attacks during the 26-week evaluation period following subcutaneous administration of Takhzyro once eve…

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J&J and Roche named to Clarivate’s Top 100 Global Innovators list 

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

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Takeda publishes Phase 3 Livtencity data in peer-reviewed journal

Takeda Pharmaceutical (TSE:4502/NYSE:TAK) has announced that it has published data from the SOLSTICE Phase 3 trial for Livtencity (maribavir) in post-transplant recipients with cytomegalovirus (CMV) infection in the peer-reviewed journal of Clinical Infectious Diseases.

The drug was statistically superior to conventional therapies at week 81. The trial met its primary endpoint. A total of 55.7% (131/235) of adult patients taking Livtencity achieved confirmed CMV DNA level under the lower limit of quantification.

It was also statistically significant to conventional therapies in a composite achievement of CMV DNA level less than the lower limit of quantification (LLOQ). In addition, the drug supported symptom control at week 8 with maintenance through week 161. The conventional therapies in the study included one or more of the antivirals ganciclovir, valganciclovir, foscarnet or cidofovir.

Last month, FDA approved Livtencity for use in patients at least …

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European initiative launched to develop COVID-19 treatment

The Corona Accelerated R&D in Europe (CARE) consortium today announced its launch to accelerate the development of COVID-19 treatments.

Supported by the Innovative Medicines Initiative, the new consortium has collected $92.7 million (€77.7 million) in grant funding in an effort to conduct a five-year project, bringing together 37 partners from Belgium, China, Denmark, France, Germany, the Netherlands, Poland, Spain, Switzerland, the UK and the U.S.

Leading the initiative is VRI-Inserm,  Johnson & Johnson‘s (NYSE:JNJ) Janssen Pharmaceutical and Takeda Pharmaceutical (TSE:4502;NYSE:TAK)  as the companies integrate partners’ COVID-19 projects that have been ongoing since February.

CARE aims to combine the researchers to accelerate the discovery and development of solutions for the current COVID-19 pandemic, as well as future coronavirus outbreaks, with the most promising drug candidates set to advance to clinical trials in humans after testing…

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