FDA approvals and expedited pathways used - New Molecular Entities (NMEs)

Empire BlueCross BlueShield (“Empire”) reviews the activities of the Food and Drug Administration (FDA)’s approval of drugs and biologics on a regular basis to understand the potential effects for both our providers and members.

 

The FDA approves new drugs/biologics using various pathways of approval. Recent studies on the effectiveness of drugs/biologics going through these different FDA pathways illustrates the importance of clinicians being aware of the clinical data behind a drug or biologic approval in making informed decisions.

 

Here is a list of the approval pathways the FDA uses for drugs/biologics:

• Standard Review – The Standard review process follows well-established paths to make sure drugs/biologics are safe and effective when they reach the public. From concept to approval and beyond, FDA performs these steps: reviews research data and information about drugs and biologics before they become available to the public; watches for problems once drugs and biologics are available to the public; monitors drug/biologic information and advertising; and protects drug/biologic quality. To learn more about the Standard Review process, click here.

• Fast Track – Fast Track is a process designed to facilitate the development, and expedite the review of drugs/biologics to treat serious conditions and fill an unmet medical need. To learn more about the Fast Track process, click here.
• Priority Review – A Priority Review designation means FDA’s goal is to take action on an application within 6 months. To learn more about the Priority Review process, click here.
• Breakthrough Therapy – A process designed to expedite the development and review of drugs/biologics which may demonstrate substantial improvement over available therapy. To learn more about the Breakthrough Therapy process, click here.
• Orphan Review – Orphan Review is the evaluation and development of drugs/biologics that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. To learn more about the Orphan Review process, click here.
• Accelerated Approval – These regulations allowed drugs/biologics for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. To learn more about the Accelerated Approval process, click here.

 

New Molecular Entities Approvals: Jan- Aug 2020

Certain drugs/biologics are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active ingredients that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients.

 

Empire reviews the FDA-approved NMEs on a regular basis. To facilitate the decision-making process, attached is a list of NMEs approved from January to August 2020 along with the FDA approval pathway utilized.

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