Hanmi Pharm's first global novel therapy Rolontis may debut soon in U.S.

[Source: Hanmi Pharmaceutical]

South Korea’s Hanmi Pharmaceutical has moved a step closer towards earning marketing clearance from the U.S. Food and Drug Administration on its long-acting neutropenia drug Rolontis (eflapegrastim).

In June, the FDA completed a due diligence on the company’s Pyeongtaek Bio Plant responsible for production of Rolontis' undiluted solution, and the company is expecting a marketing authorization notice from the FDA as early as next month, a Hanmi Pharm official said on Tuesday.

Rolontis, which was approved as the country’s 33rd novel therapy from the Ministry of Food and Drug Safety last year, is indicated for the treatment of neutropenia, an abnormally low concentration of neutrophils that help the body fight infection.

According to the Prescription Drug User Fee Act (PDUFA), the FDA will make a final decision on marketing authorization for Rolontis before Sept. 9.

Hanmi Pharm’s U.S. partner Spectrum already finalized the drug’s name as Rolvedon for the U.S. market and has increased staffing levels for local marketing and sales activities.

Rolontis would make first global novel drug from Hanmi Pharm, targeting the neutrophil care market worth about $2.2 billion in the U.S..

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