Spectrum's Rolontis hits another setback as FDA faces COVID-19 plant inspection backlog

Hanmi
FDA officials haven't been able to inspect a plant in Korea due to travel restrictions, so Spectrum's Rolontis is facing another delay. (Hanmi Pharmaceutical)

The COVID-19 pandemic has disrupted another biopharma company's plan to launch a new medicine. This time, it's Spectrum Pharmaceuticals' neutropenia candidate Rolontis—and the delay stings particularly for Spectrum after its decision to sell marketed meds and focus on R&D.

The reason for the latest delay? The company licensed the med from South Korea's Hanmi, and FDA officials haven't been able to get to Korea for a final plant inspection due to the pandemic.

While the FDA has completed inspections for manufacturing and packaging sites, the agency has yet to complete an inspection for Hanmi’s bioplant in South Korea thanks to COVID-19 travel restrictions, Korea Biomedical Review reports. The review was initially scheduled for March, but officials had to delay it twice due to the pandemic and couldn’t meet the Oct. 24 deadline.

But instead of issuing a complete response letter, the agency is merely deferring its action.

“We are actively working with the FDA to find a way to expedite the plant inspection,” Spectrum CEO Joe Turgeon said in a statement. “The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their assessment as soon as possible.” 

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Early last year, Spectrum sold its portfolio of approved drugs to focus on development efforts for Rolontis and cancer med poziotinib. Soon after, the drugmaker pulled its Rolontis application because the FDA requested more information on manufacturing, and Spectrum determined it couldn’t fulfill the request before the agency’s decision deadline.  

Meanwhile, Hanmi’s domestic application process is on track, Korea Biomedical Review reports. Authorities there have already inspected the plant, and the company expects approval within the year.

Of course, Spectrum isn’t the only drugmaker to experience a regulatory hiccup due to the pandemic. Zosano Pharma just last week received a complete response letter for its migraine drug Qtrypta in part due to travel restrictions making a facility inspection impossible. In addition, the agency highlighted the need for quality validation data with the application. 

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Before that, Intercept Pharmaceuticals experienced multiple delays for its nonalcoholic steatohepatitis drug candidate, obeticholic acid, due to scheduling issues for an FDA advisory committee meeting. The FDA ultimately rejected the drug, and Intercept had to cut staffers.