The FDA just reached into the lineup of drugs in the queue for a Q1 PDUFA date — again — and picked out La Jolla Pharmaceutical’s drug for dangerously low blood pressure to give it a record 46th new drug approval for the year.
La Jolla’s stock $LJPC climbed 16% on the news, which came two months ahead of the FDA’s deadline.
The drug — Giapreza (angiotensin II) — was handed a priority review after the agency looked over pivotal data for 321 patients. Added to current standards, it helped raise blood pressure, with 70% of the 163 patients tested with their drug achieving a pre-specified blood pressure response, compared to 23% of the 153 patients on a placebo.
But regulators also noted that it can trigger dangerous blood clots as well. And analysts have raised concerns that the safety profile could blunt its commercial prospects.
The FDA has been handing out a big batch of very early drug approvals, likely keeping their eye on the 45 new drugs CDER approved in 2015. That set a high mark for the last decade that regulators have clearly been keeping an eye on since Scott Gottlieb took the reins at the FDA, promising to speed up reviews and facilitate more drug launches. Last year, the industry managed an approval record of only half that number, marking a terrible score on productivity everyone would like to forget.
“Shock, the inability to maintain blood flow to vital tissues, can result in organ failure and death,” said Norman Stockbridge, director of cardiovascular and renal products in the FDA’s Center for Drug Evaluation and Research. “There is a need for treatment options for critically ill hypotensive patients who do not adequately respond to available therapies.”
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