New drug for neutropenia seeks FDA sanction

Park Sae-jin Reporter() | Posted : December 28, 2018, 16:05 | Updated : December 28, 2018, 16:05

[Courtesy of Hanmi Pharmaceutical]



SEOUL -- The American partner of South Korea's leading drug maker Hanmi Pharmaceutical has applied for approval to sell Rolontis, a new biologic medicine for neutropenia, an abnormally low level of white blood cells.

Hanmi said Friday that Spectrum Pharmaceuticals has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for Rolontis, which used Hanmi's technology called "Long Acting Protein/Peptide Discovery (Lapscovery)."

Lapscovery is a platform technology that prolongs the duration of action of biologics, making it possible for patients to take weekly or monthly medication or injection instead of taking them daily. Spectrum imported Lapscovery in 2012 to produce Rolontis.

Neutropenia is an abnormally decreased number of neutrophils in leukocytes due to chemotherapy or infection. Neutrophils play an important role in immunity. Spectrum found Rolontis was found to be effective and safe in clinical tests on 643 patients with early-stage breast cancer who showed an abnormally low level of neutrophils.
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