Sarepta Therapeutics, Ionis Pharmaceuticals, Biogen and Acadia Pharmaceuticals all traded lower Friday morning as investors turned up reports on their medicines on the FDA’s Adverse Events Reporting System, or FAERS.
The problem? It’s not clear whether the adverse events were caused by the medicines themselves, or were incidental, Jefferies health-care specialist Jared Holz pointed out.
Traders are “shooting first,” Holz wrote in an email.
The information sounds alarming.
Sarepta’s Exondys 51, approved last year for certain patients with Duchenne muscular dystrophy, or DMD, had 11 reports of serious cases, including three deaths, according to FAERS.
Spinraza, a treatement from Biogen and Ionis for spinal muscular atrophy, or SMA, had 101 reports of serious cases, including 12 deaths.
And Acadia’s Nuplazid, for patients with Parkinson’s, had 1,343 serious case reports, including 493 deaths, FAERS reveals.
But because the information is posted without context, it’s impossible to tell whether it should be concerning.
And biotech analyst Brian Skorney, of Robert W. Baird, said it shouldn’t be.
“Events reported to FAERS are not meant to be attributable to any drug,” Skorney wrote in an email Friday.
“Any event that occurs is reported, regardless of cause. And any drug the patient is on is also noted,” Skorney said. “There is nothing here for people to be worried about.”
The adverse event reports for Sarepta’s Exondys 51 “are generally expected outcomes of a progressive fatal disease like DMD,” Leerink analyst Joseph Schwartz wrote in a note to investors Friday.
They “are not necessarily due to any mechanistic or safety flaws of the drug itself,” Schwartz wrote.
Sarepta said Friday that the safety profile of Exondys 51 “remains consistent with previous disclosures.”
“Duchenne muscular dystrophy (DMD) is a 100 percent fatal disease that causes severe progressive muscle loss and premature death in the late-teens to 20s typically due to respiratory or cardiac complications,” Sarepta’s Ian Estepan wrote in an e-mail statement.
“The deaths reported by the FDA FAERS database were individuals in their late 20s and are consistent with the natural disease progression. The events are not believed to be related to Exondys 51.”
Biogen, in a similar statement on Spinraza, said that “based on the data reported to us to date, no deaths appear to be related to the drug.”
“All deaths reported to Biogen are then reported to the FDA in accordance with regulations,” spokesman Matt Fearer wrote in an email.
“There is no change to the benefit-risk profile of Spinraza,” he said.
Before the FDA updated the FAERS database to make it searchable, people curious about the information would have to download raw data and understand coding to be able to search it.
An FDA spokeswoman said, “Reporting of adverse events by health care professionals and consumers is voluntary in the United States. As such, there are limitations associated with the FAERS data, and the data by themselves are not an indicator of the safety profile of the drug or biologic.”
“Due to the limitations of voluntarily submitted data, the FDA encourages consumers to talk to their health care providers about any concerns they may have with safety or adverse events related to their medications.”
The FDA is no doubt seeking to increase transparency with its FAERS database.
Initially, at least, it seems to be stoking investor fears.
Correction: Sarepta’s Exondys 51 had 11 reports of serious cases, including three deaths, according to FAERS.