FDA moots a return look at Acadia’s lead drug

pharmafile | April 27, 2018 | News story | Medical Communications, Sales and Marketing Acacia, FDA, nuplazid, pharma 

Following a non-profit report that higher rates of death were associated with Acadia Pharmaceuticals’ Nuplazid, Scott Gottlieb has made comments suggesting the FDA may return to take a second look at the drug.

The FDA Commissioner was speaking in front of Congress, after being questioned over reports that emerged from CNN. The drug was approved before Gottlieb’s time at the agency, but he defended the decision to approve the treatment as long as “the patient is properly informed of what those risks are.”

“The FDA is conducting an evaluation of available information about Nuplazid,” an FDA spokesperson said. “This review has been going on for several weeks. We have nothing more to share at this time.”

Controversy emerged after the Institute for Safe Medication Practices revealed that the number of deaths associated with the drug, noted by the FDA, had risen to at least 500.

The drug, which is used for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, is expected to hit sales of $270 million for Acadia this year.

It was approved on the basis that the drug packaging would contain a black box warning, the strongest possible caution that the FDA can affix to a medication.

Acadia defended itself from the reports, at the time, by releasing a statement reading: “As part of our standard pharmacovigilance efforts, Acadia continues to regularly monitor and evaluate mortality risks for Nuplazid, and we report this quarterly to the FDA in the Periodic Adverse Drug Experience Report. Since launch, Nuplazid overall mortality rate is 14.4 per 100 patient years. It’s important to note that this is lower than overall mortality rate for PDP patients in the Medicare Claims Database (2012-2015) of 2.2 per 100 patient years.”

Shares in Acadia have dropped by half, from price of $30 at the start of the year to $15.36 at present.

Matt Fellows

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