Manufacturing problems have held back several drugs from FDA approval, and the latest example is a Tesaro drug developed to ease nausea and vomiting in cancer patients.
Tesaro (NASDAQ: TSRO) said Thursday that the FDA raised no concerns about the safety or efficacy of its drug, rolapitant, nor did the regulator ask the Waltham, MA-based company to do more clinical studies for the intravenous drug. But the FDA is asking the company to provide more information about how the rolapitant produced at one third-party manufacturing site compares to the product produced at another third-party site. Tesaro says it is working to provide that information to the regulator.
Investors took the news in stride and Tesaro shares were trading at $147.01 this morning, up 0.76 percent from Wednesday’s closing price.
Rolapitant was developed to treat chemotherapy-induced nausea and vomiting. While nausea is a problem experienced by many cancer patients who receive chemotherapy, Tesaro has plenty of company in trying to address this market. Merck’s (NYSE: MRK) aprepitant (Emend) is one of several drugs that treat the condition. The FDA approved Tesaro’s pill version of rolapitant (Varubi) in 2015. Tesaro said the FDA did not raise any concerns about the active pharmaceutical ingredient in the IV formulation, which is the same ingredient used in the rolapitant pill.
Tesaro says it has identified “potential deficiencies” at the original contract manufacturer for its IV drug and it has lined up a second drug supplier. Information from this second supplier was included in the company’s application for FDA approval. Tesaro now says it expects that the FDA could issue an approval decision on its drug sometime in the first half of this year.
A number of drug developers have made it through clinical trials only to fall short of FDA approval due to issues with the production of the drug. In 2014, Pozen, the former Chapel Hill, NC-based drug developer, cited manufacturing problems as the FDA’s reason for pushing back an approval decision on its aspirin combination drug for cardiovascular disease. Last October, Regeneron and partner Sanofi (NYSE: SNY) said that manufacturing issues delayed FDA approval on its experimental immune-disease treatment, sarilumab.