NICE (Institute for Health and Clinical Excellence) has recommended the use of Takhzyro subcutaneous injection as an option for preventing recurrent attacks of hereditary angioedema (HAE) in people aged 12 and older, within their final appraisal document (FAD), Takeda UK said in a press release Wednesday.
HAE is a rare genetic disorder that can result in unpredictable and potentially life-threatening, recurring attacks of debilitating and painful swelling in various parts of the body which can last for a number of days.
Takeda noted that NICE, the health technology appraisal body in England and Wales, has issued its Final Appraisal Determination (FAD) recommending lanadelumab subcutaneous injection as an option for preventing recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older in three cases:
1 – They are eligible for preventive C1-esterase inhibitor (C1-INH) treatment in line with NHS England’s commissioning policy
2 – The lowest dosing frequency of lanadelumab is used in line with the summary of product characteristics
3 – The company provides lanadelumab according to the commercial arrangement
Laura Szutowicz, the CEO of UK branch of the International umbrella organization for the world’s HAE patient groups, HAE UK said: “HAE attacks are unpredictable, painful and debilitating. Today’s recommendation from NICE means that people living with HAE across England and Wales have another medication that gives them the chance to lead a full and active life. We hope the NHS and Healthcare Professionals will provide swift access to patients who could benefit from this new treatment.”
Jon Neal, Managing Director, UK and Ireland, Takeda, said: “Ensuring people living with rare diseases, such as HAE, have the best care and access to innovative treatments is of the upmost importance to us and this recommendation by NICE represents a huge milestone.”
Takhzyro is approved in the U.S. (August 2018), Canada (September 2018), E.U. (November 2018), Australia (January 2019) and Switzerland (June 2019) and additional regulatory submissions are ongoing worldwide.