Today, September 26, 2024 the U.S. Food and Drug Administration approved Bristol Myers Squibb’s schizophrenia drug Cobenfy – the first truly new treatment for schizophrenia in decades: https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-COBENFY-xanomeline-and-trospium-chloride-a-First-In-Class-Muscarinic-Agonist-for-the-Treatment-of-Schizophrenia-in-Adults/default.aspx.
The new drug works differently from others on the market and has been shown to improve both positive and negative symptoms of the disease. Importantly, in clinical trials, the new drug did not cause the significant weight gain seen with older drugs – a serious side effect that has caused enormous additional health problems for people in our community.
We are proud of our leadership role in amplifying the voice of the schizophrenia community for drug developers and regulators:
· Our Externally Led Patient-Focused Drug Development (EL-PFDD) meeting with FDA spotlighted the struggles so many in our community have in finding a medicine that works for them.
· Our Capitol Hill briefing alerted FDA and policymakers to the severe access barriers to effective treatment.
Our goal: Ensure that drug developers and regulators understand what people living with schizophrenia consider to be meaningful treatment benefits and how we want to be involved in the drug development process.
New treatments have been (and continue to be) desperately needed for this severe brain disease. Now, those who fight this disease every day have a new option. We congratulate BMS on this groundbreaking achievement.
We celebrate this day with all of you as we work together to shatter the barriers to treatment, survival and recovery for people with schizophrenia!
Sincerely,
Gordon Lavigne, CEO
Schizophrenia & Psychosis Action Alliance