#Germany #Zurich #HAE #TAKHZYRO #lanadelumab

EMA Approves New Administration Option for TAKHZYRO®

In a significant move for patients suffering from hereditary angioedema (HAE), the European Medicines Agency (EMA) has granted approval for an additional 2 ml pre-filled pen option for TAKHZYRO® (Lanadelumab). This approval specifically targets teenagers aged 12 and older who frequently face attacks due to HAE. This new method of administration not only improves accessibility but also emphasizes Takeda's commitment to personalized treatment solutions for patients dealing with this complex and often debilitating condition.

TAKHZYRO® has already been recognized in the EU for routine prevention of recurrent HAE attacks in individuals starting from the age of 2. The newly approved 2 ml pre-filled pen comes as a welcome addition for adolescent and adult patients, aiming to make self-administration easier and more comfortable. The goal is to significantly reduce the burden of HAE symptoms while enhancing the overall quality of life for those affected.

According to Irmgard Andresen, Global Medical Lead of HAE at Takeda, HAE affects an estimated one in 50,000 people worldwide. Unfortunately, this condition often goes undiagnosed or untreated, leading to unnecessary suffering. The fast-tracked approval of this new delivery method reflects a proactive approach to addressing the needs of the HAE community.

As a fully human monoclonal antibody, Lanadelumab works by binding specifically to plasma kallikrein, thereby decreasing its activity. Clinical studies have shown that Lanadelumab effectively reduces the frequency of HAE attacks. The efficacy of this treatment option has been backed by extensive research, including one of the largest prevention studies for HAE.

The targeted patient population for this new option is considerable. Many families frequently find themselves grappling for years to understand this rare genetic disorder and to find suitable treatments. By providing a new administration route, Takeda aims to alleviate some of the frustrations and complications associated with HAE.

TAKHZYRO is provided in various forms including a 150 mg and 300 mg injection solution, as well as the newly introduced pre-filled pen that contains 300 mg of Lanadelumab in 2 ml of solution. The treatment can be administered at home, following proper training by healthcare professionals. However, the company advises that administration should be supervised by experienced healthcare providers to ensure proper technique and to monitor for any adverse reactions.

The side effects reported are typically mild, with injection site reactions being the most common. Nonetheless, patient safety remains a priority, and an immediate cessation of treatment may be necessary in the event of a severe allergic reaction. With only a small percentage experiencing more serious side effects, TAKHZYRO is considered a solid option for those dealing with this challenging condition.

Overall, the EMA's approval of the additional subcutaneous option marks a significant milestone not only for Takeda but also for the global HAE community. It reinforces the dedication of Takeda to lead the way in the treatment options available for this often-overlooked illness. As they align innovative solutions with patient needs, Takeda continues to pave the path toward better health outcomes for families battling HAE. This commitment to advancing medicine, improving lives, and supporting patients remains a driving force in Takeda’s mission as they advocate for those affected by rare diseases.

With the addition of the pre-filled pen for TAKHZYRO®, patients now have more flexibility in managing their treatment, thus enhancing their autonomy and improving adherence to therapy. The hopes are high that with continued research and innovation, the struggles faced by patients with HAE can be significantly reduced, allowing them to lead fuller, healthier lives.