Pfizer/AstraZeneca partnership aims to bring lasting antidepressant effect to more than 100,000 patients a year
The US Food and Drug Administration (FDA) intends to approve Pfizer’s experimental treatment for all adults who have not responded to or who fail to achieve an antidepressant response with their first antidepressant drug, according to a report from multiple news outlets.
In the negotiations that led to the agreement, Pfizer agreed to conduct late-stage clinical trials. The FDA’s approval could come in time for this year’s holidays.
The Pfizer/AstraZeneca collaboration is to bring the lasting antidepressant effect to more than 100,000 patients each year by 2023, an FDA spokesman told the Guardian. Some recently reported trials using the experimental drug, with doses similar to Pfizer’s Zecuity, have shown a statistically significant improvement in those already taking antidepressants and who were already experiencing a symptom remission compared with those who were not taking their first antidepressant, according to a post on Friday in Science Magazine by lead Pfizer scientist Priyanka Gorurkar.
The trial named SuperAgent, which was based on results from less than 5,000 patients with depression, showed that cognitive behavioral therapy was just as effective as Zecuity for the roughly 10% of depressed patients who were unable to control their symptoms. About half of all patients prescribed antidepressants receive a second one, and more than 75% of those who did not respond to their first, often effective, drug decline to depression or a relapse within six months, according to the National Institute of Mental Health.
Many of the studies of Zecuity reported at least a 69% reduction in symptoms. However, the incidence of serious adverse events was higher in Zecuity patients.
The federal agency concluded in July 2018 that the benefits of Zecuity outweigh the risks. The tentative approval signals a strong chance that depression would be treated with a drug which currently has not cleared another stage of clinical trials.
“Innovation is our job,” David Galemary, an adjunct professor of psychiatry at the Massachusetts General Hospital, told the Guardian. “You look at a group of patients and find a very select population – not everybody can benefit from [an antidepressant], but there is one that can. You make sure the treatment can work with this specific group.
“Pfizer has already done the hard part, and it has produced positive results. What’s more important is whether the company can show that the current treatment improves people’s symptoms.
“In this case, the FDA is saying they will approve the drug regardless of its safety profile. But, as they said, they still want the company to monitor the drug.”
Sharon Coven, a pharmacist at a Massachusetts drugstore chain that is also buying Zecuity, told the Wall Street Journal, “We don’t sell our medication based on marketing data.”
The US pharmaceutical industry includes dozens of companies that manufacture many different antidepressants and test and sell drugs that are experimental. A list of these companies, including Pfizer, is available through the Securities and Exchange Commission.
Scientists in the emerging field of neuroimmunology have started to use drug discovery platforms to develop drugs that recognize and suppress neuroimmunodeficiency, a group of conditions that include depression, attention deficit hyperactivity disorder and Alzheimer’s disease.
Though promising, these experimental therapies still have challenges, Coven said. These drugs can only be used temporarily, for two to five years at most, after which the immune system stops responding.
A spokeswoman for Pfizer said that as the agency works with the company to complete its review process, “the available information and views will help inform the final outcome”. The companies are expected to make the agreement official next week.
The test patient who went public with the news of the deal was rewarded with $50,000 from a philanthropic foundation funded by Pfizer. She was not identified.