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FDA Approval of First Rapid-Acting Oral Depression Drug + Approval of $2.8 Million Gene Therapy for Rare Blood Disorder – Xtalks Life Science Podcast Ep. 75

FDA Approval of First Rapid-Acting Oral Depression Drug + Approval of $2.8 Million Gene Therapy for Rare Blood Disorder – Xtalks Life Science Podcast Ep. 75

In this episode, Ayesha discussed the FDA approval of Axsome Therapeutics’ rapid-acting oral treatment Auvelity for the treatment of major depressive disorder (MDD). The approval makes Auvelity the first and only rapid-acting oral medication for depression, and the first and only oral NMDA receptor antagonist approved for MDD. Hear more about the approval, including clinical trial data showing the treatment can take effect in as little as one week, and how it is the first antidepressant approved in over 60 years that has a new mechanism of action.

Ayesha shared news about another significant FDA approval for a gene therapy to treat transfusion-dependent beta thalassemia. Bluebird bio was awarded the approval for its gene therapy Zynteglo (beti-cel), which is a one-time treatment for the rare blood disorder. Hear more about the therapy, some of the setbacks bluebird has had to face on the road to its approval and why the treatment has a steep price tag.

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Read the full articles here:

Axsome’s Auvelity Wins FDA Approval as First Rapid-Acting Oral Treatment for Depression

Bluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia

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