Nuplazid’s review was being expedited because it had been designated a “breakthrough therapy” — meaning that it demonstrated “substantial improvement” in patients with serious or life-threatening diseases compared to treatments already on the market. Congress created this designation in 2012 in an effort to speed up the FDA’s approval process, which has long been criticized for being too slow. Around 200 drugs have been granted this designation since its creation.
Still, to recommend approval, the advisory committee would have to find that the drug’s potential benefits outweighed its risks for its intended patients.
Some FDA officials concluded that Nuplazid’s public health benefit was enough to merit approval of the drug. Their argument echoed the pleas of family members and caregivers like Tyne: It could possibly help patients with no other alternative. Several of the people who spoke said their loved ones had been transformed during the clinical trials, though some said there was no way for them to know whether they were on Nuplazid or a placebo.
But the physician who led the FDA’s medical review, Dr. Paul Andreason, warned that patients taking the drug during the company’s clinical trials experienced serious outcomes, including death, at more than double the rate of those taking the placebo. The company’s limited testing, he said, had not convinced him that the benefits outweighed the risks. This has shares reeling

In a statement, the company says the overall mortality rate for the drug is 12.4/100 patient years, less than half of overall mortality rate of 28.2/100 patient years in people with PDP.

It also says it maintains a close watch on safety reports to ensure that NUPLAZID performs as expected, adding that two studies in Alzheimer’s patients (after FDA approval for PDP) with dementia showed no difference in mortality rates versus placebo.

It also cautions on drawing conclusions from the adverse event data since it does not mean that the medication caused the event.

We think shares are being slammed unfairly here, and think a speculative trade can be considered

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