How does CTIX fast track Kevetrin?
Fast track is usually applied for in phase two. It allows much greater access to FDA throughout whole trial process and will shorten review process after final trial completion. Drug must fulfill unmet medical need(can do this just by being superior to any existing therapy) and treat serious disease. After being granted fast track status, company can also apply for accelerated approval. FDA will offer much guidance on this to the company as part of the increased FDA access company has for fast track. Accelerated approval can be obtained if company can back up their case with verifiable lab data as secondary endpoint, ie, 'our drug shrinks tumors'and this approval can save them years in getting drug to market. FDA requires post marketing studies (phase 4 study) for any accelerated approval drug, ie, 'your drug shrinks tumors and that's great, but you still have to prove that it helps people live longer'.
http://www.nationalaglawcenter.org/assets/crs/RS22814.pdf
What we do know from material on the FDA website:
! Manufacturers have requested Fast Track designation for 569 drugs and
195 biological products since the Fast Track program was set into law.
! FDA granted the designation to 74.5% of those drug requests and 63.6%
of those biologics requests.
! Of products with Fast Track designation, FDA eventually approved
10.6% of the drugs and licensed 17.7% of the biologics.6
Fast Track submissions in theory differ from routine NDA/BLA submissions because
they address unmet needs in the treatment of life-threatening or serious conditions.
Similar criteria apply to drugs that FDA gives Priority Review status. In fact, 80% of Fast
Track NDA approvals were also given Priority Review, as were all of the approved Fast
Track BLAs. Again, FDA makes public detailed data only regarding the products that it
approves/license.
http://www.fas.org/sgp/crs/misc/R41983.pdf
Accelerated approval. FDA regulations allow “accelerated approval” of a drug or biologic product that provides a“meaningful therapeutic benefit ... over existing treatments.” The rule covers two situations. The first allows approval to be based on clinical trials that, rather than using standard outcome measures such as survival or disease progression, use “a surrogate endpoint that is reasonably likely ... to predict clinical benefit.” The second situation addresses drugs whose use FDA considers safe and effective only under set restrictions that could include limited
prescribing or dispensing. FDA usually requires postmarketing studies of products approved this way.
Fast track. The Food and Drug Administration Modernization Act of 1997 (FDAMA, P.L. 105-115) directed the Secretary to create a mechanism whereby FDA could designate as “Fast Track” certain products that meet two criteria. First, the product must concern a serious or life-threatening condition; second, it must have the potential to address an unmet medical need. Once FDA grants a Fast Track designation, it encourages the manufacturer to meet with the agency to discuss development plans and strategies before the formal submission of an NDA. Such early
interaction can help clarify elements of clinical study design and presentation that if absent at NDA submission could delay approval decisions. However, FDA makes similar interactions available to any sponsor who seeks FDA consultation throughout the stages of drug development.
Priority review.
Unlike Fast Track or Accelerated Approval, the Priority Review process begins only when a manufacturer officially submits an NDA. Priority Review, therefore, does not alter the timing or content of steps taken in a drug’s development or testing for safety and effectiveness. Although Priority Review is not explicitly required by law, FDA has established it in practice, and various statutes, such as the Prescription Drug User Fee Act (PDUFA), refer to and sometimes require it. When FDA determines that a product would address an unmet need, it places it through Priority Review. That designation results in an average turnaround time (from completed application to approval decision) of approximately 6 months, rather than the 10-month average for Standard Review.
