Pre-filled pen version of Takhzyro approved in Europe
Subcutaneous injection for hereditary angioedema patients 12 and older
The European Medicines Agency (EMA) has approved a new pre-filled pen version of Takhzyro (lanadelumab) as a treatment for people, 12 and older, with hereditary angioedema (HAE), according to an announcement from Takeda, the company that markets Takhzyro.
The new pen option contains 300 mg of lanadelumab, Takhzyro’s active ingredient, in a 2 mL solution. It’s designed for easy administration of the therapy via subcutaneous (under-the-skin) injection.
“We welcome the swift approval by the EMA on this additional subcutaneous administration option,” Irmgard Andresen, MD, global medical lead for HAE at Takeda, said in a company press release.
In HAE patients 12 and older, the recommended dosage of Takhzyro is one 300 mg injection every other week. In patients weighing less than 40 kg (about 88 pounds), a starting dose of 150 mg every two weeks may also be considered. In patients who are stably attack-free, dosing may be reduced to one injection every four weeks.
Before pen option, Takhzyro was available in Europe in pre-filled syringes
Before the approval of the pre-filled pen option, Takhzyro was available in Europe in pre-filled syringes containing either 150 or 300 mg of the medication, or in a vial containing 300 mg of the therapy.
“HAE patients 12 years and older now have an additional individualized treatment option available to them,” Andresen said.
HAE is a genetic disorder marked by swelling attacks driven by the excessive production of a signaling molecule called bradykinin. The production of this signaling molecule is mediated by an enzyme called kallikrein. Takhzyro works to block the activity of the kallikrein enzyme, thereby reducing bradykinin levels and ultimately preventing swelling attacks.
Takhzyro is currently approved in the European Union for HAE patients as young as 2. It is approved in the U.S. for the same age range and has also been approved for similar indications in other countries, including Australia, Canada, Japan, and China.
Approvals of Takhzyro for HAE patients 12 and older were based mainly on data from a Phase 3 clinical trial called HELP (NCT02586805), which showed the therapy was better than a placebo at preventing swelling attacks.
The EMA’s decision to approve the pen option for patients in this age group was based on data from a clinical trial (NCT03918239) that compared the amount of the medication available in the body when the pre-filled syringe or pen was used to administer 300 mg of Takhzyro to healthy adult volunteers.
Results showed either option delivered comparable amounts of the therapy’s active ingredient into the body, implying that both versions should be equally effective when used as treatment for people with HAE.
The therapy’s dose in children as young as 2 is based on body weight. Because the pre-filled pen option hasn’t been tested in younger children, it should not be used in these patients. Takhzyro should, instead, be administered via a pre-filled syringe or vial in such cases.
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