LL schreef op 19 april 2022 12:18:
TAKHZYRO nieuwsTAKHZYRO® (lanadelumab-flyo) Prefilled Syringe Now Available for HAE Patients in the United States
TAKHZYRO® (lanadelumab-flyo) injection single-dose prefilled syringe is now available in the U.S. to prevent attacks of HAE in adult and pediatric patients 12 years of age and older. Approved by the U.S. Food and Drug Administration on 8 February 2022, the TAKHZYRO prefilled syringe is ready to use and requires fewer preparation steps than the single-dose vial, enhancing the treatment administration experience.
“By introducing TAKHZYRO prefilled syringe to the HAE community, our aim is to continue to enhance the patient experience. With this advancement, those taking TAKHZYRO can now live their life with a ready-to-use option that requires fewer steps and less waste than when using the single-dose vial to receive their injection,” says Cheryl Schwartz, Senior Vice-President, Rare Disease Business Unit at Takeda Pharmaceutical Company Limited. “Over the coming months, we will be working with patients and their specialty pharmacies as they are ready to make the transition.”
With a proven efficacy and safety profile and real-world experience, TAKHZYRO has been available in the U.S. since 2018 helping to prevent HAE attacks in patients 12 and older. TAKHZYRO is supported by a robust clinical development program, which includes one of the largest prevention studies in HAE with the longest active treatment duration, HELP (Hereditary Angioedema Long-term Prophylaxis) Study™. Results from the HELP Study Open-Label Extension (OLE) found consistent safety and efficacy results with TAKHZYRO in a treatment period of up to 132 weeks.
“HAE attacks are unpredictable, debilitating and in some cases life-threatening, adding uncertainty and complexity to the daily lives of those living with this disease and their families,” says Dr. William Lumry, Allergy Immunology Specialist, Clinical Professor of Internal Medicine, University of Texas Southwestern Medical School. “After many years in practice witnessing the ups and downs of this disease, I welcome any opportunity to simplify the process of administering an effective prevention therapy for people living with HAE.”TAKHZYRO® (lanadelumab) Open Label Phase 3 Study Met its Objectives
The Phase 3 SHP643-301 study evaluating the safety profile and pharmacokinetics of TAKHZYRO® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives. The safety profile was consistent with that seen in the clinical program for patients 12 years of age and older; there were no serious adverse events and no dropouts due to adverse events.
The study also successfully reached the secondary objective evaluating the clinical activity/outcome of TAKHZYRO in preventing HAE attacks as well as characterizing the pharmacodynamics of TAKHZYRO in pediatric subjects 2 to <12 years of age.
“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,” says Ashley Yegin, Global Medical Unit Head, HAE, Global Medical Affairs, Takeda. “With more than a decade of experience and innovation in HAE, Takeda is committed to continued support for patients of all ages with this devastating condition.”
“I’m pleased that TAKHZYRO has met these key objectives and I look forward to Takeda sharing further insights with the HAE community in the near future,” says Dr. Marcus Maurer, Professor of Dermatology and Allergy Charité – Universitätsmedizin Berlin, Germany and principal investigator of SHP643-301.
Participants aged 2 to < 6 years received lanadelumab at a dose of 150 milligrams (mg) every 4 weeks (q4wks) over 52-week treatment period. Participants aged 6 to <12 years received lanadelumab at a dose of 150 mg every 2 weeks (q2wks) over 52-week treatment period. This study is complete, and full results will be presented at upcoming medical meeting(s).