Teva Pharmaceuticals Seeks FDA Greenlight For New Schizophrenia Treatment

• TEV-'749 is designed to help improve patient adherence.  
• The treatment utilizes a copolymer technology proprietary to Medincell to provide a controlled steady, sustained release of olanzapine.
• Earlier this week, the United States Court of Appeals for the Federal Circuit issued a ruling backing Teva in a patent dispute involving Corcept Therapeutics’ Korlym tablets.

U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA) said on Friday that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension or TEV-'749 for the treatment of schizophrenia in adults.

The application was based on data from a late-stage trial in which TEV-'749 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection monitoring.

Shares of TEVA traded marginally lower at the time of writing.

Drug Details

Currently, long-acting olanzapine formulations require administration in a certified healthcare facility and require a 3-hour post-injection monitoring period. TEV-'749 is designed to help improve patient adherence.  

“Treatment adherence remains a major challenge and unmet need for people living with schizophrenia…,”   said Eric Hughes, Chief Medical Officer at Teva. The treatment utilizes a copolymer technology proprietary to Medincell to provide a controlled steady, sustained release of olanzapine.

Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts, and symptoms may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability. As per the company, about 1% of the world’s population will develop schizophrenia in their lifetime.

Teva is best known for its generics business. Earlier this week, the United States Court of Appeals for the Federal Circuit issued a ruling backing Teva in a patent dispute involving Corcept Therapeutics’ Korlym tablets.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around TEVA stayed within the ‘bearish’ territory while message volume stayed at ‘low’ levels.

TEVA stock has more than doubled over the past 12 months. 

Read More: Praxis Precision Shares Rally On Price Target Hikes: Analyst Sees Upside As High As 100% For Stock

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