Hereditary vascular edema (HAE) innovative products! Takeda Takhzyro pre-filled syringes will soon be approved in the European Union and will be available this year! !
Last Update: 2020-06-17
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, 2020 //BiovalleyBIOON/Takeda recently announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Commission (CHMP) has issued an active review recommending approval of Takhzyro (lanadelumab) pre-filled syringesTakhzyro, a prescription drug for subcutaneous injections, has been approved for routine prevention ofrecurrence of inheritedangioedema (HAE) in patients 12 years of age and olderThe European Commission (EC) is expected to make a decision on approval within the next two monthsTakeda expects to launch Takhzyro pre-filled syringes in Europe later this year, which will improve the treatment management experience for HAE patients treated with Takhzyrohae
HAE is a raregeneticdisease that causes repeated edema- and swelling in various parts of the body, including the abdomen, face, feet, genitals, hands and throatTakhzyro is the first monoantinodrug approved for HAE in the European Union and the United StatesTakhzyro was approved by the European Union in November 2018 based on the results of the Phase III HELP (
long-term prevention of inheritedvascular edema)This large-scale preventive study involved 125 patients aged 12 and over with Type I/II HAE who evaluated the efficacy and safety of subcutaneous injection Takhzyro and placebo treatment for 26 weeks The results showed that the study reached the full primary and secondary endpoint: patients treated with three Takhzyro regimens had significantly fewer HAE seizures per month than the placebo group Among them, a 300 mg dose of Takhzyro treatment group (n-27) every 2 weeks significantly reduced the number of HAE seizures per month by 87 percent compared to the placebo group currently available in a small bottle of 300mg of injections Pre-filled syringes are the next generation fully assembled products that require fewer preparation steps than current small bottles, while reducing supply and waste "Our goal is to innovate in all areas of HAE management," said Isabel Kalofonos, head of global product strategy at Haida, This positive review of CHMP marks another important step forward, and our goal is to improve the management experience of the patient population receiving Takhzyro We look forward to bringing this pre-filled syringe innovation to the HAE community in Europe starting later this year and continuing to push ahead with plans to expand to other parts of the world in the coming months "
hereditary edema (HAE) is a rare genetic disease that can cause repeated edema-swelling in various parts of the body, including the abdomen, face, foot, genitals, hands and throat Swelling can cause weakness and pain Seizures that block the airways can cause asphyxia and can be life-threatening HAE attacks affect about 1 in 50,000 people worldwide and the disease is often underrated, diagnosis inadequate and undertreated Takhzyro is an all-human monoantiphopha, which binds specifically and inhibits the activity of plasma kinetic peptide release enzymes The drug is produced using recombinant DNA technology in Chinese hamster ovary cells (CHO) Takhzyro is administered by subcutaneous injection, with a half-life of 14 days in HAE patients, and after training by a medical professional, the injection can be done in 1 minute or less by the patient's own administration or by a caregiver In terms of medication, Takhzyro's recommended starting dose is 300 mg per 2 weeks In patients treated with well-controlled non-seizures, a dose of 300 mg per 4 weeks can be considered, especially in low-weight patients (BioValleyBioon.com) original source: Takeda Receives Positive CHMP Opinion for Pre-filled Syringe Presentation of TAKHZYRO? (lanadelumab) for use as a A Treatment for Hereditary Angioedema Attacks
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