Plus   Neg

FDA Approves Pill With Sensor Abilify MyCite; Otsuka Stock Up


Schizophrenia drug Abilify MyCite becomes the first drug approved in the U.S. with a sensor that digitally tracks if patients have ingested their medication. The U.S. Food and Drug Administration on Monday approved Abilify MyCite (aripiprazole tablets with sensor), developed by Otsuka Pharmaceutical Co., Ltd.

In Japan, Otsuka Holdings' (OTSKF.PK) shares were gaining around 2.7 percent at 4,762 Japanese yen.

In a statement, the FDA noted that the product has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

According to FDA, Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or may not occur.

Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said, "Being able to track ingestion of medications prescribed for mental illness may be useful for some patients. The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers."

Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

The sensor technology and patch are made by Proteus Digital Health.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT