Tìm theo
ALTU-135
Thuốc Gốc
Biotech
ALTU-135, the Company's orally administered enzyme replacement therapy for patients with pancreatic insufficiency, is manufactured by blending three drug substance enzymes: lipase, protease and amylase. This consistent and pure enzyme combination is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals. ALTU-135 has been granted orphan drug and fast-track designation as well as CMA Pilot 2 program status by the Food and Drug Administration (FDA).
Cơ Chế Tác Dụng : ALTU-135, the Company's orally administered enzyme replacement therapy for patients with pancreatic insufficiency, is manufactured by blending three drug substance enzymes: lipase, protease and amylase. This consistent and pure enzyme combination is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals. ALTU-135 has been granted orphan drug and fast-track designation as well as CMA Pilot 2 program status by the Food and Drug Administration (FDA). As ALTU-135 consists of three enzymes, lipase, protease and amylase that are delivered in a consistent ratio and is designed to improve fat, protein, and carbohydrate absorption in pancreatic insufficient individuals. ALTU-135 is designed to be highly concentrated, stable and pure and to allow patients to take a single capsule per meal or snack, whereas current products are derived from pig pancreases and require a significantly higher pill burden. This reduced pill burden for ALTU-135 is expected to provide greater convenience for the patient and result in improved compliance and therefore effectiveness. ALTU-135 has been granted Orphan Drug designation in the United States and Europe. ALTU-135 was also granted fast track designation by the U.S. Food and Drug Administration (FDA) in November 2003, and was accepted into the FDA’s Continuous Marketing Application Pilot 2 Program in February 2004.
Chỉ Định : Investigated for use/treatment in cystic fibrosis and pancreatic disorders.
Dữ Kiện Thương Mại
Nhà Sản Xuất
  • Công ty :
    Sản phẩm biệt dược : TheraCLEC
  • Công ty :
    Sản phẩm biệt dược : Trizytek
Tài Liệu Tham Khảo Thêm
drugbank
http://www.drugbank.ca/drugs/DB05330
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