Med Check
EU Approves First Antidepressant With Cognition Claims
Previous studies have shown a range of cognitive symptoms—including difficulties in thinking and remembering new information—to be associated with major depression. In March, Brintellix (vortioxetine) became the first antidepressant approved in the European Union (EU) to improve cognitive symptoms in patients with depression.
“We are delighted that Brintellix has received this positive opinion from the CHMP [Committee for Medicinal Products for Human Use], particularly given the role cognitive deficits play in impacting treatment outcomes for many patients,” said Anders Gersel Pedersen, M.D., Ph.D., executive vice president and head of research and development at Lundbeck, manufacturer of Brintellix.
The antidepressant’s claims of improving cognition were approved after the CHMP reviewed comprehensive data from an international clinical program composed of five studies assessing the safety and efficacy of Brintellix as well as the medicine’s effects on cognitive function and performance. These were assessed by various neuropsychological tests, such as the Digit Symbol Substitution Test, in patients with major depression.
Brintellix became available in the United States, where it is copromoted by Takeda, more than a year ago and is gradually being introduced across the EU.
FDA Launches Mobile App on Medication Shortages
Information on drug shortages can now lie in the palm of your hand. Last month, the Food and Drug Administration (FDA) launched its first mobile app specifically designed to increase public access to data on current shortages, resolved shortages, and discontinuations of drug products.
“Health care professionals and pharmacists need real-time information about drug shortages to make treatment decisions,” said Valerie Jensen, R.Ph., associate director of the Drug Shortage Staff in the FDA’s Center for Drug Evaluation and Research. “The new mobile app is an innovative tool that will offer easier and faster access to important drug shortage information.”
Users may be able to access information on medications based on therapeutic category, such as “psychiatry.” Current psychotropics on the shortage list are attention-deficit/hyperactivity medications dexmethylphenidate hydrochloride (Focalin) tablets and methylphenidate hydrochloride extended release capsules, the antipsychotic haloperidol lactate injection, and the antidepressant trimipramine maleate (surmontil) capsules.
The app is available for free download via iTunes (for Apple devices) and the Google Play store (for Android devices) by searching “FDA Drug Shortages.”
Company Halts Studies of Alzheimer’s Drug
Development for the Alzheimer’s drug category BACE (beta-site amyloid precursor protein cleaving enzyme 1) inhibitors started with a grim first quarter of the fiscal year.
Last month, Vitae Pharmaceuticals and Boehringer Ingelheim announced that they have put a hold on studies concerning their newly codeveloped BACE inhibitor BI 1181181 after observing skin rashes in patients enrolled in a phase 1 dose-ranging study.
“Our partner is working diligently to evaluate and understand this observation,” said Vitae Chief Scientific Officer Richard Gregg, M.D. “Depending on the outcome of the evaluation, … we expect that either BI 1181181 or its structurally distinct phase-1-ready backup will be advanced with the goal of delivering a medicine with disease-modifying benefits to patients suffering from Alzheimer’s disease.”
The setback is the latest in a series of missteps for BACE inhibitors, a highly sought-after therapy in the field of Alzheimer’s drug development. Eli Lilly’s BACE program was scrapped for off-target toxicity in studied individuals. Roche killed off its BACE program for unexplained reasons, and Astellas, without explanation, backed out of a $760 million deal with CoMentis on another early-stage BACE drug program.
As for Vitea, Gregg stated that the company will remain committed to its partnership with Boehringer and the progression of the joint BACE program. ■
