Chiesi Global Rare Diseases Announces FDA Approval of Lamzede®(velmanase alfa-tycv) for Alpha-Mannosidosis
BOSTON, Feb. 16, 2023 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today that the U.S. Food and Drug Administration (FDA) has approved Lamzede® (velmanase alfa-tycv) for the treatment of non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and pediatric patients. AM is an ultra-rare, progressive lysosomal storage disorder caused by deficiency in the enzyme α-mannosidase.
- "Today's approval of Lamzede represents a major milestone for people living with alpha-mannosidosis.
- Lamzede is the first and only enzyme replacement therapy approved for alpha-mannosidosis in the United States, an achievement based on years of clinical development, as well as the dedication of our employees, clinicians, patients and their families," said Giacomo Chiesi, head of Chiesi Global Rare Diseases.
- The prevalence of AM is approximately one in every 500,000 to one in every 1,000,000 babies born worldwide.
- For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment with Lamzede.