Overview
Title
Sage Therapeutics, Inc.; Withdrawal of Approval of a New Drug Application for ZULRESSO (Brexanolone) Solution, 100 Milligrams/20 Milliliters
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ELI5 AI
The FDA has stopped approving ZULRESSO, a special liquid medicine used by Sage Therapeutics, because it's not being sold anymore. Sage told the FDA this, and any leftover ZULRESSO can still be used until it's all gone or goes bad.
Summary AI
The Food and Drug Administration (FDA) has decided to withdraw its approval of the new drug application (NDA) for ZULRESSO (brexanolone) solution, which was previously held by Sage Therapeutics, Inc. This decision comes after Sage Therapeutics informed the FDA that the drug is no longer being sold and requested the withdrawal. The withdrawal of approval is effective as of April 14, 2025. It is important to note that any remaining ZULRESSO products can still be used until they are sold out, expire, or become unusable after the withdrawal date.
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for ZULRESSO (brexanolone) solution, 100 milligrams (mg)/20 milliliters (mL), held by Sage Therapeutics, Inc., 55 Cambridge Parkway, Cambridge, MA 02142 (Sage). Sage notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
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AnalysisAI
The document from the Federal Register announces the withdrawal of FDA approval for a drug called ZULRESSO (brexanolone) solution. This drug application was originally held by Sage Therapeutics, Inc. The withdrawal became official after Sage communicated to the FDA that the drug was no longer being sold, and the company requested the withdrawal of its application. The approval was formally withdrawn as of April 14, 2025.
General Summary
The FDA's notice reflects a routine administrative process where a drug's approval is rescinded following the manufacturer's decision to discontinue its marketing. Sage Therapeutics decided not to sell ZULRESSO anymore and subsequently asked the FDA to withdraw the drug's application. This means that, post-withdrawal date, the sale or distribution of the drug without a renewed approval could result in legal issues. Yet, existing stocks can be used up, sold, or disposed of in accordance with expiry norms or until they're deemed inadmissible.
Significant Issues or Concerns
A close reading of the document identifies several issues worthy of discussion. Firstly, the notice does not provide precise reasons for Sage Therapeutics' decision to halt marketing ZULRESSO, leaving stakeholders in the dark about any underlying factors contributing to this choice. Secondly, the document makes regulatory references that may be obscure for those unfamiliar with specific FDA procedures or legal terminologies, potentially limiting the accessibility of the information for the general public.
Moreover, the lack of discussion on the financial or economic implications of withdrawing such a drug could be viewed as a gap. This might be of particular interest given the ramifications such decisions can have on pharmaceutical stakeholders and healthcare providers. Lastly, while it is noted that Sage waived its right to a hearing, the document does not explain the implications or reasons for this waiver, which could otherwise provide further context to the withdrawal.
Impact on the Public
Broadly speaking, for the general public, this withdrawal indicates that ZULRESSO will no longer be available once existing inventory is exhausted. Patients and healthcare providers who might rely on this specific treatment will either have to secure remaining stock or seek alternative treatments. This could potentially be challenging for patients who have grown accustomed to the drug and have not yet identified substitutes.
Impact on Stakeholders
Patients and Healthcare Providers will need to adapt quickly to this change. Those relying on ZULRESSO may face a transitional period as they either adjust to a different medication or approach to treatment.
Sage Therapeutics will likely see an impact from discontinuing a marketable product. If market conditions compelled them to withdraw the drug, this could have other notable impacts on their portfolio, profitability, or research directions.
Pharmacists and Distributors will have to manage their inventories judiciously, ensuring compliance with the post-withdrawal regulations. They must also communicate effectively with patients and healthcare professionals regarding the availability or lack thereof of ZULRESSO.
While the withdrawal from the market is a regulatory action, it indeed holds a significant ripple effect on various facets of pharmaceutical operations, healthcare provisions, and patient care dynamics.
Issues
• The document does not describe any spending or financial implications related to the withdrawal of the drug approval, which might be relevant information.
• The language regarding the implications of introducing ZULRESSO into interstate commerce without approval could be clarified to better inform stakeholders of the legal consequences.
• The document uses regulatory references (e.g., § 314.150(c)) without providing a brief explanation or context for those not familiar with the regulations, making it less accessible to the general public.
• No specific reasons are given for why Sage Therapeutics, Inc. decided to stop marketing ZULRESSO (brexanolone) solution, which could help in understanding the context of the decision.
• The document briefly mentions that Sage has waived its opportunity for a hearing without explaining the potential rationale or implications of this decision.