WASHINGTON — The FDA approved the first drug with a specific indication for postpartum depression, while an FDA advisory committee panned a new non-drug treatment for Alzheimer‘s disease with shaky efficacy data.
But due to concerns about risks, such as excessive sedation or loss of consciousness, the drug will only be administered with a Risk Evaluation and Management Strategy (REMS) that includes a “restricted distribution program.” This means the drug will be administered by a healthcare provider in a certified healthcare facility, where patients can be monitored after administration, the agency said in a statement.
“This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option,” added Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA‘s Center for Drug Evaluation and Research.
“The agency has been given every opportunity to act in the interest of the American public,” said Raeford Brown Jr., MD, chairman of the FDA‘s Anesthetic and Analgesic Drug Products Advisory Committee, on a phone call with reporters. “At the direction of the former commissioner, Robert Califf, MD, the FDA spent many tax dollars to engage the National Academies [of Science, Engineering, and Medicine] in an effort to define the agency’s responsibility for the current and ongoing problems with prescription opioids and establish a new way forward in the regulatory process consistent with the existing statutory authority provided by Congress.”
“This process was finished more than 1½ years ago with a powerful report accepted by the current commissioner that’s been supported by the scientific and health community,” Brown continued. “However, the agency has yet to respond to substantial changes suggested by the academies. Those of us that study the activities of the FDA have yet to observe behaviors indicating the agency is prepared to accept responsibility for the opioid crisis and substantially change the regulatory framework.”
Members of an FDA advisory committee didn’t take a formal vote on the neuroAD Therapy System for treating Alzheimer‘s disease at their meeting Thursday, but there appeared to be a consensus that its sponsor’s trial data failed to demonstrate a clinically meaningful benefit in patients with mild to moderate symptoms.
Many members of the Neurological Devices Panel saw potential in the data Neuronix presented and encouraged the company to consider developing a new study, looking perhaps at a group of Alzheimer‘s patients with milder dementia or using a different trial design.
“I think we all think there’s probably a signal here,” said panel member David Knopman of the Mayo Clinic in Rochester, Minnesota. But the data Neuronix presented is “hypothesis-generating to do a study better,” he continued. “I don’t see that what we have before us is something that could be approved.”
FDA Warns of Off-Label Use for Venclexta
Interim results from a trial of venetoclax (Venclexta) in multiple myeloma, showing an apparent mortality risk with the drug, prompted the FDA not only to put a partial hold on the trial, but also to warn the larger oncologist community about the risk. After about two years in the 291-patient BELLINI trial, overall mortality was doubled in the venetoclax group.
Multiple myeloma is not a currently approved indication for the drug. The agency suggested, however, that “health care professionals, oncology clinical investigators and patients” should be aware of the risks when used off-label for this indication.
The FDA emphasized that the mortality risk doesn’t appear to extend to approved indications, which include chronic lymphocytic leukemia, small lymphocytic leukemia, and acute myeloid leukemia under certain conditions.
Cardiac Contractility Device Approved for Select HF Patients
The cardiac contractility boosting Optimizer Smart system is now approved for chronic, moderate-to-severe heart failure not suited for other heart failure device therapy, the FDA announced.
The device gained an indication to improve 6-minute walk distance, quality of life, and functional status for New York Heart Association class III heart failure with reduced ejection fraction (25% to 45%) that remains symptomatic on optimal medical therapy. Other required criteria were a regular heart rhythm and ineligibility for cardiac resynchronization therapy (QRS <120 ms on ECG).
Approval followed the overwhelmingly favorable recommendation in December by an FDA advisory committee for the implantable pulse generator using non-excitatory electrical pulses to increase ventricular contractile strength.
The Optimizer had “breakthrough device” designation from the FDA for filling an unmet clinical need for this population that couldn’t get other implantable devices.
“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” said Bram Zuckerman, MD, of the Division of Cardiovascular Devices in the FDA‘s Center for Devices and Radiological Health, in a press release.
On Monday and Tuesday, the FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee will review data on breast implant safety, including risk of lymphoma as well as the devices’ structural integrity and means of monitoring them after placement.
On Tuesday, the Senate Health, Education, Labor and Pensions Committee will discuss implementation of the 21st Century Cures Act.
And the Senate Committee on Veteran’s Affairs will discuss the VA’s FY 2020 budget and FY 2021 advance appropriation request.
Also, Roll Call will explore a broad array of healthcare issues during its “Healthcare Decoded” briefing.
And the House Committee on Education and Labor will explore efforts to strengthen the prevention and treatment of child abuse and neglect.
On Wednesday and Thursday, Academy Health will host the “Health Datapalooza” conference.
Also on Wednesday, the House Committee on Appropriations will examine the VA’s FY 2020 budget request.
On Thursday, the Heritage Foundation will assess “the medical harms of hormonal and surgical interventions for gender dysphoric children.”