Drug Discovery and Development

European regulators approve Janssen’s twice-yearly schizophrenia treatment

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JanssenTwo months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), Janssen has won approval from the European Commission for Byannli, a six-month formulation of paliperidone palmitate.

Indicated as a maintenance treatment for adults with schizophrenia, Byannli won approval based on results from the Route 6 study, which found that 92.5% of patients receiving the therapy were relapse-free at 12 months.

The Phase 3 study was a randomized, double-blind, non-inferiority trial including 702 adults with schizophrenia.

The drug won FDA approval in September, but its trade name in the U.S. is Invega Hafyera.

To be eligible for the drug, patients must be clinically stable on either once-monthly paliperidone palmitate (PP1M) or three-monthly paliperidone palmitate (PP3M).

Janssen formulated the drug to have exceptionally low water solubility, enabling it to offer continuous absorption over six months.

 

 

Filed Under: clinical trials, Drug Discovery, Psychiatric/psychotropic drugs
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About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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