US EditionFDA Advisors Give PTSD Drug Combination a Thumbs Down
UNITED STATES, JUL 18 – The FDA panel voted 10-1 against approving brexpiprazole with sertraline for PTSD due to insufficient evidence of efficacy, leaving limited pharmacotherapy options for patients.
- In 2024, the US Food and Drug Administration approved 127 innovator and biosimilar drugs, a decline from 149 approvals in 2023.
- A remarkable surge in innovative approvals emerged, GlobalData said, highlighting small pharmaceutical companies and CDMO disruptors Helix Biotech and Minaris Advanced Biotech.
- The approvals include key biosimilar milestones, such as the first biosimilars of Stelara, Wezlana, and denosumab, Wyost and Jubbonti, according to GlobalData.
- Following Wednesday’s review, the US Food and Drug Administration Psychopharmacologic Drugs Advisory Committee voted 10 to 1 against recommending brexpiprazole adjunctive to sertraline for PTSD, aligning with FDA staff reviewers.
- No new FDA action date has been been set, leaving clinicians and patients in a challenging situation.
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MedPage Today
Anti-Aging, Acupuncture and Health NewsFDA Advisors Give PTSD Drug Combination a Thumbs Down
(MedPage Today) -- FDA's outside experts weren't sold on the trial data for brexpiprazole (Rexulti) as an adjunctive treatment for post-traumatic stress disorder (PTSD), sinking its prospects for approval in this setting. In a 10-1 vote on Friday...
US FDA advisers vote against Otsuka's PTSD combination treatment
(Reuters) -The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's drug when used in combination with Viatris' Zoloft for the treatment of adults with PTSD.
Otsuka, Lundbeck’s PTSD Drug Fails to Win US FDA Panel Support
Otsuka Pharmaceutical Co.’s medicine for post-traumatic stress disorder with partner H. Lundbeck A/S failed to win the backing of US regulatory advisers, a major setback in the drugmakers’ bid to bring the first new drug for the condition to market in more than two decades.
Brewing Purpose After the Battle: How Zero Dark Thirty is Combating PTSD with Coffee and Community in Boise - The Boise Beat
A Boise coffee shop founded by a Marine veteran is turning espresso into a mission of healing for those battling PTSD. What happens when the uniform comes off but the war inside doesn’t end? For many veterans and first responders, the answer is isolation, suppressed trauma, and invisible wounds. PTSD affects an estimated 20% of post-9/11 veterans, but few talk about it, and even fewer find a healthy outlet to heal. That’s exactly why Zero Dark T…
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