With La Jolla's $500M Giapreza nod, FDA breaks a high-water mark for approvals

The FDA approved its 46th med this year, passing 2015's high point for recent years.

The latest drugmaker to benefit from a year-end sprint at the FDA is La Jolla Pharmaceutical Company, which picked up the agency's 46th approval of the year on Thursday. The company's Giapreza passed agency gatekeepers as a treatment for adults with dangerously low blood pressure.

With the approval in hand, La Jolla plans a March 2018 launch for a med that analysts believe could generate half a billion dollars at peak. In a statement, critical care expert John A. Kellum, M.D., of the University of Pittsburgh called the approval a "major advance" for treating the patient group.

In a note following the approval Thursday evening, SunTrust analyst Yatin Suneja wrote that the med won a "relatively broad label" that "compares favorably" to Endo's Vasostrict, which generated $343 million last year. His team expects the drug to be used initially as a third-line treatment, after norepinephrine and vasopressin have failed. But Giapreza could get some second-line use as well, Suneja said.

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The San Diego biotech has already hired a commercial leadership team for the launch—La Jolla's first—and will deploy a field sales force in January, according to the analyst. Suneja wrote that he expects the med to produce $500 million in peak sales in the U.S., adding that there's an underappreciated opportunity in Europe as well.

Giapreza's approval represented the FDA's 46th this year, eclipsing 2015's high of 45 and setting a new record—in recent history, at least. The nod comes closely on the heels of approvals for Merck and Pfizer's SGLT2 diabetes drug Steglatro and Aerie's Rhopressa to treat glaucoma. Last year, the agency approved just 22 new meds.

La Jolla's stock was up about 9% before the market opened on Friday.