Wednesday was a good news-bad news sort of day for AstraZeneca's Seroquel XR. The extended-release antipsychotic did get an FDA advisory panel's nod for a new use--against depression--but it was far from an unqualified yes. The panelists unanimously agreed that Seroquel shouldn't be a first-line treatment for depression, because it's not safe enough for such widespread use. It could be useful, however, as a supplemental drug for some patients, they said, in a 6-to-3 vote.
AstraZeneca was pitching the committee on a proposed expansion of Seroquel use not only to patients with major depression, but to those with generalized anxiety disorder as well. Panelists determined that Seroquel wasn't significantly more effective than established depression meds as a first-line, standalone treatment. Plus, the drug's well known potential to cause weight gain, high blood sugar and other serious side effects caused concern. "I would expect unintended consequences associated with wide-scale use of the drug," said the panel's chair, Dr. Wayne Goodman of NIMH.
Now that its experts have weighed in, it's up to FDA to make a choice. The agency isn't required to follow the panel's advice, but it usually does.
Despite the endorsement's limits, it could still boost Seroquel sales, observers said. "It's certainly going to help their bottom line, but it's not the great victory they had hoped for," Daniel Carlat, a Tufts University psychiatrist who was not on the advisory panel, told the Philadelphia Inquirer. Carlat said companies can use even narrow approvals to market a drug more widely.
- read the Delaware News-Journal's story
- see the article in the Inquirer