BigBear Pharma (BIGBEARPharma) in Laos announced that its generic version of Lusutrombopag, LUTRODX, has received marketing authorization from the Lao Ministry of Health, making it one of the first generic versions of this oral thrombopoietin receptor agonist in Southeast Asia.
Is there a generic version of Lusutrombopag available in Laos?
Yes, there is a generic version of Lusutrombopag in Laos. The Lao BigBear version of Lusutrombopag is available in the strength of3mg*7 tablets/box. For more questions, we recommend that you add our professional customer service for detailed consultation.
Indications for Lusutrombopag
On July 31, 2018, the U.S. Food and Drug Administration (FDA) officially announced the approval of the new drug Lusutrombopag (generic name: lusutrombopag) developed by Shionogi & Co., Ltd. This drug is indicated for specific adult patients with chronic liver disease and thrombocytopenia who are scheduled to undergo surgery or invasive procedures. This approval marks an important advancement in the treatment of thrombocytopenia associated with chronic liver disease. The FDA had accepted the application for this drug in February of the same year and granted it Priority Review status. Lusutrombopag is an oral thrombopoietin (TPO) receptor agonist that promotes platelet production by stimulating megakaryocytes in the bone marrow, thereby increasing platelet counts in patients and reducing the risk of bleeding related to surgery. This mechanism of action provides a new therapeutic option for patients with chronic liver disease who cannot safely undergo surgery due to excessively low platelet counts. Previously, such patients often relied on platelet transfusions to ensure surgical safety, and the availability of Lusutrombopag is expected to reduce dependence on exogenous platelet transfusions. Notably, this drug had already been approved in Japan in 2015 for improving thrombocytopenia associated with chronic liver disease. The FDA approval in the U.S. was based on rigorous clinical trial data, providing strong support for the drug's safety and efficacy.
How effective is Lusutrombopag as a treatment?
The FDA approval of Lusutrombopag was primarily based on two randomized, double-blind, placebo-controlled multicenter clinical trials – L-PLUS1 and L-PLUS2 (ClinicalTrials.gov identifier: NCT02389621). The two studies enrolled a total of 312 patients with chronic liver disease and severe thrombocytopenia who were scheduled to undergo invasive procedures, with baseline platelet counts below 50×10⁹/L. Patients were randomly assigned to receive either once‑daily oral Lusutrombopag 3 mg or matching placebo for 7 consecutive days. In the L-PLUS1 study,
