Galectin Therapeutics Inc. (GALT)

[BelizeBeachTrader]

You are looking at what the timing would be under regular approval. GALT is not going to speculate and post on its website on accelerated approval times.


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Transcript: Accelerated Approval Program video
Return to Accelerated Approval Program page
Captain Mary Kremzner: When it comes to treating serious or life-threatening diseases, speeding drug development and delivery is in everyone's interest. The Accelerated Approval Program is one way the FDA helps make new, potentially lifesaving drugs available more quickly. Hi, I'm Captain Mary Kremzner and this is Drug Info Rounds brought to you by the pharmacists in the FDA's Division of Drug Information. I'm joined by FDA pharmacist, Commander Catherine Chew, who will examine the Accelerated Approval process and what it means for the medical community. Cat, can you provide a little context about the origins and intentions of the program?

Commander Catherine Chew: Absolutely. When starting a new drug, Mary, as you know it can take a very long time, oftentimes several years, to definitely demonstrate a clinical benefit and then go through the process of securing FDA approval. In 1992 the FDA instituted its Accelerated Approval Program as a way to speed new drugs to market that treat serious diseases and fill an unmet medical need.

Captain Mary Kremzner: Now Cat, exactly how does the FDA determine when an expedited approval is warranted?

Commander Catherine Chew: Generally drugs are approved under Accelerated Approval if they have the potential to impact factors, things like survival, day-to-day function or the likelihood of stopping a disease from progressing and becoming an even more serious condition.

Captain Mary Kremzner: Now Cat earlier you mentioned filling an unmet medical need. How would you define that?

Commander Catherine Chew: An unmet medical need simply means providing a therapy when none exists or providing a new therapy that may be superior to or less toxic than an existing one.

Captain Mary Kremzner: So without the standard clinical outcomes how does FDA determine if a treatment is potentially effective?

Commander Catherine Chew: Great question Mary. Accelerated Approvals use what we call a surrogate end point in clinical trials. These are markers or a physical sign of sorts used as an indirect measurement to predict a clinically meaningful outcome like survival or symptom improvement.

Captain Mary Kremzner: So exactly how does the surrogate end point save time in the drug approval process?

Commander Catherine Chew: Well for example, instead of having to wait to learn if a drug prolonged survival in cancer patients the FDA has approved drugs based on evidence that they shrink tumors. As a surrogate end point, tumor shrinkage is reasonably linked to real clinical benefit.

Captain Mary Kremzner: Okay, so let me make sure I have this. Let’s say a drug goes through Accelerated Approval and gets to market, how do we know if it really provides that clinical benefit?

Commander Catherine Chew: Any approvals given based on surrogate end points are on the condition that the sponsor will conduct post-marketing clinical trials to verify the anticipated benefit. If these trials, called Phase 4 Confirmatory Trials, shows the drug does in fact provide a clinical benefit then and only then does the FDA grant traditional approval for that drug.

Captain Mary Kremzner: Worst case scenario, Cat, what if the drug fails to prove that clinical benefit?

Commander Catherine Chew: In that case the FDA has a series of regulatory procedures in place that could eventually lead to the drug’s removal from the market.

Captain Mary Kremzner: The Accelerated Approval Program strikes just the right balance between safety and speed which can make all the difference to patients with serious or life-threatening diseases. If you have questions about the Accelerated Approval Program, call or email the FDA’s Division of Drug Information.





http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm313852.htm