Takhzyro Archives - Medical Design Sourcing

A closer look at the potential of Takeda’s Takhzyro in pediatric hereditary angioedema study

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

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

FDA first approved Takyzyro for heditary angiodema in 2018 for patients 12 years and older with types I and II HAE. The drug won marketing authorization throughout the European Union that same year.

To learn more about the study, we reached out to Dr. Marcus Maurer, professor of dermatology and allergy at Charité – Universitätsmedizin Berlin, Germany and principal investigator of the SPRING study.

Drug Discovery & Development (DDD): The 94.8% reduction in HAE attacks for children aged 2 to <12 seems remarkab…

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…

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…