PRINCETON, N.J., Jan. 28, 2021 /PRNewswire/ -- Sandoz, a global leader in generic and biosimilar medicines, today announced the US launch of generic Icatibant injection pre-filled syringe to treat acute attacks of rare disease hereditary angioedema (HAE) in adults 18 years and older.1 It is available immediately for US patients.
Sandoz has signed a US commercialization deal with Slayback Pharma, a company focused on producing complex generic and specialty pharmaceutical products, for this medicine, which is a generic equivalent to Takeda's Firazyr®* (icatibant injection).
"We are eager to see the positive effects of making generic Icatibant available immediately to people living with this painful and disabling rare disease," said Keren Haruvi, President, Sandoz Inc. "This collaboration aligns with our goal to build our injectables portfolio and provide US patients access to affordable generic medicines that work the same as brand-name products."
Hereditary angioedema is a rare disease characterized by recurrent episodes of severe swelling of the skin and mucous membranes. Swelling of the airways and throat can be extremely dangerous and potentially lead to death. Patients can also suffer nausea, vomiting, diarrhea and abdominal pain.2
"With our strong developmental capabilities and Sandoz's industry-leading commercialization of its extensive portfolio of generic medicines, we couldn't be more excited to collaborate with Sandoz and help people living with hereditary angioedema," said Ted Smolenski, Vice President of Business Development at Slayback Pharma.
Slayback Pharma is a pharmaceutical company focused on the development and commercialization of complex generic and specialty pharmaceutical products, with a team of 90 employees and operations in the US and India. Slayback has a proven track record of numerous sole first-to-file ANDAs, 505(b)(2)s and complex generic filings, approvals and commercial launches.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS Laryngeal attacks: Following treatment of laryngeal attacks with icatibant injection, advise patients to seek immediate medical attention.
ADVERSE REACTIONS The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash.
DRUG INTERACTIONS Icatibant injection is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where icatibant injection may attenuate the antihypertensive effect of ACE inhibitors.
USE IN SPECIFIC POPULATIONS Elderly patients demonstrate increased systemic exposure to icatibant. Differences in efficacy and safety between elderly and younger patients have not been identified.
INDICATION Icatibant injection is a bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
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About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical need. Our ambition is to be the world's leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2019 sales of USD 9.7 billion.