Yuhan Corp. is to roll out a high-dose generic drug of Agrylin Cap. (ingredient: anagrelide) soon, after returning sales rights of Shire’s original drug. Yuhan’s generic copy is a second of its kind, with the first marketed by Pharmbio Korea.
The Ministry of Food and Drug Safety on Thursday approved Yuhan to distribute Anagre Cap. 1mg for treating thrombocytosis from myeloproliferative disorder, a rare, intractable disease. The drug reduces elevated platelet levels, the risk of thrombosis, and thrombotic-bleeding tendencies.
The effect of platelet reduction is related to the drug dose. A high-dose treatment can quickly lower platelet counts. Pharmbio Korea recently obtained the nod for a high-dose 1mg product.
Yuhan and Pharmbio Korea aim to meet the needs of patients who want a faster reduction of platelets with high-dose therapies.
Yuhan started selling Shire’s Agrylin in 1988 but returned its sales rights in 2016 due to Shire’s entry into the local market.
Also in 2016, Yuhan won approval for Anagre Cap. 0.5mg, a generic drug of Agrylin.