NICE recommends Takeda’s Takhzyro for NHS use to prevent hereditary angioedema attacks

pharmafile | September 18, 2019 | News story | Research and Development, Sales and Marketing NHS, NICE, Takeda, Takhzyro, pharma 

UK drug watchdog NICE has announced its final draft guidance recommending Takeda’s subcutaneous injection Takhzyro (Lanadelumab) for use on the NHS in England and Wales for the prevention of recurrent attacks of hereditary angioedema (HAE).

The recommendation covers patients older than the age of 12 who are eligible for preventive C1-esterase inhibitor (C1-INH) treatment in line with NHS England’s commissioning policy

A rare genetic disorder, HAE is characterised by recurring attacks which cause swelling in the abdomen, face, feet, hands, throat and genitals, often lasting a number of days. The condition can even become life-threatening due to asphyxiation occurs due to swelling which obstructs the body’s airways.

Supporting the decision was Phase 3 data which demonstrated that, compared to placebo, Takeda’s drug reduced the average number of monthly HAE attacks by 87% when administered at 300mg fortnightly, and 73% when administered at the same dose one every four weeks. Over 26 weeks of treatment, 44% of Takhzyro patients remained attack-free, compared to just 2% of placebo patients.

“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,” commented Laura Szutowicz, Chief Executive Officer at HAE UK.  “We hope the NHS and Healthcare Professionals will provide swift access to patients who could benefit from this new treatment.”

Dr Sinisa Savic, Consultant in Clinical Immunology and Allergy, also remarked: “The replacement of frequent intravenous injections with at-home subcutaneous administration every two to four weeks, and the chance of being attack free, means that lanadelumab has the potential to transform care for some patients. It represents a real step-change in the treatment and clinical management of patients who experience recurrent HAE attacks.”  

Takhzyro has already secured approval in major markets over the past few years, including the US in August 2018, Canada in September 2018, the EU in November 2018, Australia in January 2019 and Switzerland in June 2019.

Matt Fellows

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