Otsuka, Allergan, and BMS Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Otsuka, Allergan, and Bristol-Myers Squibb.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, November 8, 2017 to Tuesday, November 15, 2017.

FDA OKs Otsuka’s Digital Health Drug
The US Food and Drug Administration has approved Otsuka Pharmaceutical’s and Proteus Digital Health’s Abilify MyCite (aripiprazole tablets with a sensor), a drug-device combination product comprised of Otsuka’s oral aripiprazole tablets embedded with Proteus’ digital ingestion tracking system, for treating schizophrenia, bipolar disorder, and depression.

Specifically, the product was approved for treating 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.

The drug has an ingestible sensor embedded in the pill that records the amount of the medication that was taken. The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phones. The sensor technology and patch are made by Proteus Digital Health, a Redwoods Shores, California-based digital healthcare company. 

Abilify, as a tablet without the tracking system, was approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was permitted for marketing by the FDA in 2012.

Source: Otsuka Pharmaceutical and  Proteus Digital Health

Allergan Gets FDA OK for New Use of Bipolar Drug Vraylar
The US Food and Drug Administration (FDA) has approved Allergan’s supplemental new drug application for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia.

Vraylar, an oral, once-daily atypical antipsychotic, is also approved in the US for treating adults with acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.

Source: Allergan

FDA OKs Pediatric Use of BMS’ Leukemia Drug Sprycel
The US Food and Drug Administration (FDA) has expanded the indication for Bristol-Myers Squibb’s Sprycel (dasatinib) tablets to include treating children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase (CP).

This approval for Sprycel in pediatric patients with Ph+ CML in the chronic phase was granted under priority review and the indication received orphan drug designation from the FDA.

Sprycel is indicated for treating adults with: newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase; chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib; Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.

Source: Bristol-Myers Squibb


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