A Treatment for Neutrophilia
The U.S. Food and Drug Administration is expected to conduct due diligence on Hanmi Pharmaceutical's plant in Pyeongtaek sometime in May. The FDA will inspect the production facilities for Hanmi’s neutrophilia drug Rolontis. Originally scheduled for October 2020, the due diligence was postponed due to the COVID-19 pandemic.
Rolontis was licensed out to Spectrum of the United States in 2012. As a consequence, Spectrum has the right to sell the drug in the global market excluding Korea.
Neutrophilia is a disease in which the number of white blood cells drops to 4,000 to 10,000 per microliter of blood.
Hanmi Pharmaceutical plans to step up its efforts to obtain FDA approval for Rolontis by the end of 2021. It has already completed preparations necessary for approval.
If the due diligence is successfully completed, the FDA is expected to approve sales of Rolontis between June and July. If the FDA approves Rolontis, it will become the sixth new drug developed in Korea to obtain FDA approval. The latest FDA approval was given to SK Biopharm's new epilepsy syndrome drug Cenobamate in 2019.