Manufacturing, New Products

FDA rejects Tesaro’s IV version of rolapitant, citing manufacturing issues

Mary Lynne Hedley, Tesaro President & COO

Tesaro’s plans for building up sales of Varubi — or rolapitant — through a new intravenous formulation of the drug will have to wait. The FDA shot down the biotech’s marketing application, which the biotech says is solely during to some outstanding manufacturing issues.

The pill version of the drug — used to treat chemo induced nausea and vomiting — was OK’d back in 2015, triggering a blockbuster projection from the company. Analysts, though, have been less than impressed with the rollout, with Leerink pulling back its forecast on sales.

Regulators did not question the safety and efficacy of the IV version, Tesaro reported, but did have issues with the biotech’s switch of manufacturers. After identifying “potential deficiencies” at the first manufacturer, developers provided regulators with in vitro evidence of comparability in terms of the drug being manufactured.

The FDA is looking for additional information and Tesaro says it plans to provide it as expeditiously as possible.

Tesaro’s shares were down about 3% in pre-market trading on Thursday.

This is the latest in a long string of CRLs prompted by manufacturing issues over the past year, as the FDA plays hardball on production quality with companies big and small.

While Tesaro won’t be helped by the delay, the big focus at the company remains niraparib, a PARP inhibitor that gained priority review status at the FDA just ahead of Christmas.

Tesaro president and COO Mary Lynne Hedley said:

Tesaro is committed to bringing this new intravenous formulation of rolapitant to physicians and patients to enable additional flexibility and choice of antiemetic regimens, and we plan to address FDA’s questions expeditiously and complete this application, which we expect to enable approval in the first half of 2017.


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