Neurocrine Biosciences’ Ingrezza is first FDA-approved drug for tardive dyskinesia
WASHINGTON — The Food and Drug Administration approved Neurocrine Biosciences’ Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition.
Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue and smacking the lips. Some affected people also experience involuntary movement of the extremities or difficulty breathing.
"Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness," said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. "Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition."
Tardive dyskinesia is a serious side effect sometimes seen in patients who have been treated with antipsychotic medications, especially the older medications, for long periods to treat chronic conditions, such as schizophrenia and bipolar disorder. Tardive dyskinesia can also occur in patients taking antipsychotic medications for depression and certain medications for gastrointestinal disorders and other conditions. It is unclear why some people who take these medications develop tardive dyskinesia yet others do not.
The efficacy of Ingrezza was shown in a clinical trial of 234 participants that compared Ingrezza to placebo. After six weeks, participants who received Ingrezza had improvement in the severity of abnormal involuntary movements compared to those who received placebo.
McKesson publishes white paper integrating behavioral coaching to boost adherence
SAN FRANCISCO– In conjunction with its sponsorship of the CBI Conference, McKesson on Tuesday announced the launch of a new whitepaper discussing how brands can effectively combat nonadherence by integrating behavioral coaching into comprehensive patient support programs.
“The convergence of drug prices and patients’ rising financial obligations increases the likelihood of medication nonadherence by patients. Fortunately, there are effective tools to mitigate the risk of financially motivated primary fill abandonment,” stated Reagan Tully, VP product strategy for McKesson Specialty Health.
“However, it’s important to realize that most nonadherence is the result of behavioral barriers, such as low self-efficacy, lack of engagement or medication concerns, and addressing these is critical to improving compliance to a course of therapy," she said. "Leveraging behavioral coaching across communication channels, hub services and pharmacy channels allows brands to reach patients where they are within their treatment journey to build an integrated patient experience, drive positive health outcomes and increase medication adherence.”
At the conference, Tully led a session titled “Formulary Breakthroughs — Moving Beyond Co-Pay Programs to Encourage Collaboration and Improve Patient Outcomes.” The session addressed key payer challenges within the market impacting patient out of pocket costs. The discussion focused on new methods for manufacturers to collaborate with payers and explore innovative, implementable solutions to ease patient cost burden, ultimately to drive patient adherence and outcomes.
Alere Reader, a point-of-care influenza diagnostic, gains 510(k) clearance
WALTHAM, Mass. – Alere on Tuesday announced that its Alere Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings, has received 510(k) marketing clearance from the U.S. Food and Drug Administration.
“The Alere BinaxNOW Influenza A & B Card 2 test with the Alere Reader, improves what is already a leading rapid testing solution for influenza diagnosis in two key ways – by eliminating operator subjectivity and by connecting test results with information management systems,” stated Avi Pelossof, Alere Global president of infectious disease. “The Alere Reader platform, paired with Alere’s market-leading lateral flow portfolio, will ensure that over time this novel technology will be accessible for use with a wide variety of diseases and conditions across numerous clinical settings.”
With the Alere Reader, physicians, lab technicians and other healthcare personnel insert test cards into the platform, which detects, identifies and analyzes the completed lateral flow assay. Results are displayed on an intuitive touch screen, can immediately be linked to patient electronic medical records and back-end information systems, or can be printed. Further, the Alere Reader provides the user additional confidence in the results with an automated function that ensures quality controls have been tested.
This announcement represents the introduction into the U.S. market of the Alere Reader, a diagnostic platform with objective result interpretation and connectivity capabilities. This follows a successful release of the Alere Reader into Europe and select Asian markets.