La Jolla Pharmaceutical (NASDAQ: LJPC) shares surged by 12.5% as of 12 p.m. EST Friday after the FDA approved the company's first commercial drug.
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Earlier this year, La Jolla Pharmaceutical reported positive phase 3 results data for Giapreza (formerly LJPC-501), a medicine that can help patients suffering from a life-threatening drop in blood pressure. Management filed for FDA approval shortly thereafter, but a decision from the regulator wasn't expected until Feb. 28, 2018.
Instead, the FDA gave La Jolla Pharmaceutical and its investors a Christmas present, approving Giapreza about two months ahead of schedule.
In trials, Giapreza successfully increased the proportion of patients achieving a mean arterial pressure of at least 75 mmHg, or a 10 mmHg increase from baseline, three hours following the initiation of treatment, without increasing the need for standard-of-care vasopressors.
The company is targeting a March 2018 launch for Giapreza, so we won't get any insight into how rapidly doctors and hospitals will add it to their treatment arsenals until the second quarter.
That said, there is an opportunity for this drug to become a meaningful source of sales for La Jolla Pharmaceutical. There's a relatively high mortality rate associated with shock patients who don't respond to existing treatment options, and the addressable market of Giapreza is on the scale of hundreds of thousands of patients per year in the U.S. alone.
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