Takeda launches CINRYZE™ in India, the first C1-I NH for prophylaxis in hereditary angioedema patients

New Delhi, XX December 2022: Takeda Biopharmaceuticals India Private Limited (formerly known as Baxalta Bioscience India Pvt. Ltd.), a global values-based, R&D-driven biopharmaceutical leader launched CINRYZE™ an innovative injectable prescription medicine for the treatment of hereditary angioedema (HAE) patients. With eight years of global clinical experience proving efficacy and safety, CINRYZE™ has the potential to mark a breakthrough in the episodic treatment, short and long-term prophylaxis for HAE. Moreover, CINRYZE™ is the pioneer C1 esterase inhibitor (C1-I NH) approved by the FDA & EMA for the symptomatic management of HAE and for preventing future angioedema attacks.[2]

CINRYZE™ is indicated in India for:
Routine prevention (prophylaxis) of angioedema attacks in adults, adolescents and children 6 years of age and above with HAE[3].

Treatment of angioedema attacks and pre-procedure prevention of angioedema attacks in adults, adolescents and children 2 years of age and above with HAE [3].

Speaking at the launch, Serina Fischer, General Manager, Takeda Biopharmaceuticals India Private Limited said, “At Takeda, we are committed to bringing innovative treatment to fulfil the unmet medical needs across our core therapy areas. We are confident that the launch of Cinryze will bridge the gap in the treatment of HAE patients in India. The launch furthers our commitment towards rare diseases patients in India.”

Sony Paul, Franchise Head, Rare Diseases, Takeda Biopharmaceuticals India Private Limited added, “As per data, there are likely to be more than 30,000[4] undiagnosed patients at present in the country. These patients are suffering due to the lack of diagnosis and treatment. With the launch of Cinryze, our aim is to reduce acute attacks of HAE and support the prevention of HAE attacks by prophylactic regime thus improving the quality of life of HAE patients.”

Hereditary Angioedema (HAE) is a rare genetic condition that causes swelling in different parts of the body like limbs, face, abdomen, and larynx [5,6]. HAE is caused by a mutation in the gene which produce protein called the C1 esterase inhibitor leading to its reduced level or compromised functioning. [6] Symptoms of HAE often present in childhood, and while attacks can occur at any age, early onset may predict a more severe disease course [6]. Attacks often occur in children without a clear trigger,[5] and may affect a child’s participation in school, activities, and sports, which can leave them feeling socially isolated [7,8]. It can be life-threatening in severe cases in which the swelling attacks can manifest in the larynx (voice box), or trachea (windpipe) [5,6].

The disease is usually identified by recurrent episodes of fluid accumulation outside the blood vessels, causing rapid swelling of body tissues. The symptoms of HAE could be like an allergic reaction; however, the potential outcome could be life-threatening in case of HAE. Due to the lack of awareness among healthcare professionals, HAE is highly underdiagnosed in the country.

Takeda Biopharmaceuticals India Private Limited (formerly known as Baxalta Bioscience India Private Limited) is a part of Takeda Pharmaceutical Company Limited’s group of companies headquartered in Japan. The company focuses on immunology, genetic diseases, haematology, oncology and gastrointestinal portfolios in the country. As a global leader in pharmaceuticals, Takeda has been focusing on driving comprehensive research to support the development of effective and innovative treatments in the company’s chosen therapy areas.

HAE, hereditary angioedema; QoL, Quality of life; FDA, Food and Drug Administration; EMA, European Medicines Agency

References:
Lumry WR, Castaldo AJ, Vernon MK, et al. The humanistic burden of hereditary angioedema: Impact on health-related quality of life, productivity, and depression. Allergy Asthma Proc. 2010;31:407-14.

Cinryze®. USFDA PI. March 2022. Cinryze®. SmPC EMA. October 2020

CINRYZE®. Indian PI. Feb 2022.

Jindal AK, Bishnoi A, Dogra S. Hereditary Angioedema: Diagnostic Algorithm and Current Treatment Concepts. Indian Dermatology Online Journal. 2021;12(6): 796-804. https://doi.org/10.4103/idoj.idoj_398_21

Cicardi M, Bork K, Caballero T, et al. Evidence-based recommendations for the therapeutic management of angioedema owing to hereditary C1 inhibitor deficiency: consensus report of an International Working Group. Allergy. 2012; 67(2):147-157.

Zuraw BL. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.

Read N, Lim E, Tarzi MD, et al. Patient hereditary angioedema: a survey of UK service provision and patient experience. Clin Exp Immunol 2014; 178:473-88.

Mendivil J, Murphy R, Cruz Mdl, et al. Clinical characteristics and burden of illness in patients with hereditary angioedema: findings from a multinational patient survey. Orphanet Journal of Rare Diseases. 2021 (16).

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