MK-2866: FDA Fast Track Designation Approved!

MK-2866: FDA Fast Track Designation Approved!

MK-2866: FDA Fast Track Designation Approved!
Another important step in the Phase 3 trial of Ostarine to get FDA approval!

MK-2866: FDA Fast Track Designation Approved!

Wait? What?

MK-2866 Going To Phase 3!

Yes, you are hearing this right.
The ARTEST Phase 3 trial gets an FDS Fast Track designation approval!

MK-2866 (Ostarine) is one of the most researched SARMs already and did undergo a lot of clinical trials upon phase 2.
We already got you up to speed about the phase 3 trials for Ostarine in previous articles.
And today we can give you another big update on the FDA Fast Track approval for the phase 3 trial for Ostarine.

 

So What Does It Mean?

MK-2866: FDA Fast Track Designation Approved!

This means that MK-2866 is in the last accelerated pathway to get approved by the FDA for human use.
In short, you could say that the FDA thinks it is very important that this phase 3 research goes fast and well.
It also means they recognize the possibility that Ostarine may be the best future option for this kind of use.

The short definition: Fast Track designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs. The purpose is to get important new drugs to patients faster.

 

More on FDA Fast Track Designation

Goal

Fast Track designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs. The purpose is to get important new drugs to patients faster. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapy. Drugs that are granted this designation are given the opportunity for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval: more frequent written communication with FDA about such things as the design of the proposed clinical trials and use of the biomarker.

Requirements for Fast Track

There are 3 big requirements for the approval of Fast Track designation:

  • The drug needs to treat or cure a serious condition
  • There is an unmet medical need
  • It has must have an advantage over a current therapy if there is one

Serious Condition

Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition if left untreated, will progress from a less severe condition to a more serious one.
AIDS, Alzheimer’s, heart failure, and cancer are obvious examples of serious conditions.
However, diseases such as epilepsy, depression, and diabetes are also considered to be serious conditions.

Unmet medical need

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapy.

The advantage over current therapy

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

  • Showing superior effectiveness, effect on serious outcomes or improved effect on the serious outcome
  • Avoiding serious side effects of an available therapy
  • Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
  • Decreasing clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment
  • Ability to address emerging or anticipated public health needs

Advantages of Fast Track

There are a lot of advantages being approved for Fast Track designation:

  • Frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
  • Frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarker
  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
  • Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by the FDA.
    They don’t have to wait until every section of the NDA is completed before the entire application can be reviewed.

Overall, once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process.
The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

 

Short Recap

The ARTEST Phase 3 trial gets an FDS Fast Track designation approval!
This means that MK-2866 is in the last accelerated pathway to get approved by the FDA for human use.
This also means the FDA believes

The most important things to remember are:

  • The FDA believes there is a need to speed up and support the phase 3 trial for Ostarine.
  • Faster resolving of problems or questions due to faster communication between Veru and the FDA
  • The phase 3 trial might end sooner so that Ostarine will get approval for human use faster

We will follow these developments thoroughly and keep you up to date about future results!

 

As an extra for our Knowledge Vault, we will do more news flashes regarding all of our research compounds.
So you always can find all the latest info about these compounds here!

MK-2866: Another Phase 3 Trial?

Don’t forget: at Rat’s Army, you will find these products in the best quality around, at competitive pricing, and in multiple variants!
Make sure you visit our shop soon to start your own research with these wonderful compounds!

 

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