FDA rejection thwarts Otsuka's hopes for Abilify adherence boost

Otsuka and partner Proteus Digital Health envisioned a new version of the antipsychotic Abilify that could track patients and their doses. But the FDA was underwhelmed by the partners' drug-plus-device application, saying that it needs more information before it could consider an approval.

The FDA says it needs more information about the product's use, and it wants the companies to investigate the possibility of human error. Otsuka and Proteus were asked to “evaluate use-related risks and confirm that users can use the device safely and effectively,” the companies said in a statement.

Otsuka has a lot riding on an FDA approval for the new twist on Abilify. The original antipsychotic brand is facing a generic onslaught now that it’s off patent, and a longer-acting formulation, Abilify Maintena is now battling a new version from Alkermes.

Unsurprisingly, Tokyo-based Otsuka and California-based Proteus are “disappointed” with regulators’ decision not to approve their hybrid drug-and-device tool, Otsuka EVP Robert McQuade said in a statement.

But Otsuka and Proteus “are committed to working with the FDA to address its questions and provide the additional data that has been requested,” the company told FiercePharmaMarketing in an email.

The companies are staying quiet about next steps for gaining approval for their product, though. “We are reviewing the (FDA’s) request and do not have a specific timeline to share at this point,” Otsuka and Proteus Digital Health said. “We believe in the potential of this product to help people with serious mental illness manage their daily medication, which remains a serious unmet need.”

The prospective product melds Otsuka’s antipsychotic blockbuster Abilify and Proteus’ ingestible sensor, which the FDA has already approved separately. Proteus’ sensor sends a signal to a wearable patch after it gets to the stomach, and the patch then sends the information back to a mobile phone or Bluetooth device.

Persuading patients on antipsychotic drugs to stick to their meds can be a challenge, and the two partners saw this digital-tracking capability as a selling point for psychiatrists worried about adherence. The delay only gives Abilify generics more time to make inroads on the branded pill; last April, the FDA approved Abilify generics from companies such as Alembic Pharmaceuticals, Hetero Labs, Teva ($TEVA) and Torrent Pharmaceuticals.

And as of October, Abilify has faced yet another competitor: Alkermes' ($ALKS) long-acting injectable version, which could further put a dent in Otsuka's sales.

Still, Otsuka is doing everything it can to staunch the bleeding. In July, the company got FDA approval for antipsychotic Rexulti, which is set to bring in an estimated $1.4 billion in peak sales. Abilify Maintena, Otsuka and Lundbeck’s long-acting formulation of the antipsychotic, could also deliver. Analysts expect peak sales between $500 million and $1 billion for the med.

- read the statement
- here’s FierceMedicalDevicestake

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