Chiesi Group’s Lamzede Gets FDA Approval for Rare Genetic Disorder
The Chiesi Group has received FDA approval for Lamzede (velmanase alfa-tycv) for treatment of adult and pediatric patients with non-central nervous system manifestations of alpha-mannosidosis, a rare genetic disorder characterized by an inability to break down complex sugars.
Lamzede is a recombinant form of human alpha-mannosidase to provide or supplement natural alpha-mannosidase, an enzyme involved in degradation of mannose-rich oligosaccharides.
The FDA required a boxed warning with the product that some patients treated with Lamzede have experienced hypersensitivity reactions, including anaphylaxis.
Pretreatment with antihistamines, antipyretics and/or corticosteroids should be considered before administering Lamzede, the agency said.
About Chiesi
Chiesi Farmaceutici S.p.A. is an Italian family controlled global pharmaceutical company based in Parma, Emilia-Romagna. Chiesi has 30 affiliates in the world, nearly 6,389 total employees and provides medicines to patients in 90 nations. Chiesi currently has revenues of 2.229 billion euros. According to 2021 official data from the European Patent Office (EPO), Chiesi Group, with 38 patents filed, is confirmed the first Italian Pharmaceutical Company and fourth among Italian Companies across all sectors for filing the highest number of patents.
In June 2019, Chiesi became a certified B Corporation, thus choosing to adopt a new legal status under US and Italian law. This ensures Chiesi a legal protection to pursue a business model placing social and environmental values on equal footing with profits. Following the acquisition, in 1999, of Huddersfield based Trinity Pharmaceuticals, Chiesi has also had a significant presence in Manchester, United Kingdom.
February 21, 2023
