Launching into a drug in a larger indication

of one

Dual Drug Launch 1

A detailed, in-depth search of drugs that fit within your parameters could not be located based on several factors involved in the query. Primarily, an understanding of the way drugs are approved through the FDA and how they are launched in the market demonstrates that what you are looking for may not be available. Further clarification is needed in order to properly pare down the thousands of potential drugs on the market that may fit with what you’re looking for, so we can provide relevant case studies.
Please note that, due to the nature of this request, some sources are older than would typically be found in Wonder’s research.


The query noted you were looking for drugs that had small launches (“prevalence less than 200,000 for first indications”) and later larger launches (“prevalence >1,000,000 patients”), though the terminology used (“prevalence”) is used not for launch (and/or population) sizes. Rather, it is used to denote how many people are affected by the disease for which the drug is intended, as noted here in AdvancedRenalEducation. So, from this point of confusion, we sought clarification by diving into the research.
Our initial findings showed that the first terminology used here indicates drugs that are used to treat diseases that affect fewer than 200,000 patients (so-called “Orphan Drugs”). In researching these drugs, there are no Orphan Drugs for the diseases you are most interested in (diabetes, cardiovascular conditions, and liver diseases) since these affect a much-larger population than Orphan Drugs are indicated for. Additionally, it does not appear that drugs in this class have been released later for treating similar (or other) diseases affecting a larger number of people, and thus the terminology and correct meanings do not mesh with our findings. So, if Orphan Drugs actually are what you are looking for, you can visit this source or this one to get more information. Both sources provide specific information on the pricing (and pricing changes) for Orphan Drugs, so they may be useful to you either way.
Next, we approached this from a different perspective, looking for drugs that were released for treating one disease, then were re-released (or re-approved) for treating another disease. Unfortunately, our research showed that this typically means a drug with more than one indication listed (meaning it is used to treat more than one disease like the above-paragraph indicates), so it gave us no new direction in which to go. However, if this is the information you wanted, you can find a wealth of it here, here, here, or here.
At the same time, we focused our research in attempting to find drugs that launched twice – once only to small populations and then again later for larger populations (like from one area to the whole country, for example). Unfortunately, our research has shown that the FDA does not approve the release of a drug in two different waves (like for a smaller then a larger population), but rather, the organization approves drugs for specific indications, then, in some cases, those drugs are also applied to off-label uses (or those things not approved by the FDA, but shown to work). This does not constitute a second release of the drug, only additional uses for it.
In addition to our own search strategies, we also tried the approach you recommended to our interpreter (“look at all FDA approvals from 2009 to today, exclude oncology and focus on smaller indications for the first launch”). Unfortunately, as indicated, a search of the last three years’ data (2015, 2016, 2017) did not turn up any drugs that were approved more than once, nor did it turn up information on drugs that were launched into the market more than once.
At this point, we refocused toward looking at all drugs that have been approved over the last 10 years in the US for the conditions on which you’re focusing (diabetes, cardiovascular conditions, and liver diseases). Since this is an extensive list (of thousands of different drug classes and individual drugs), we worked to sort through the items, looking at approval dates, names, and the like, in an attempt to pare it down and find several drugs that matched your requirements on approvals / launches. Considering the other information we’ve explained here, no drugs were found that match your parameters. Additional information on what we did find is outlined below.


According to ScienceDirect, “74 medications (including generic), belonging to 12 different classes and in 19 different combinations, have been approved (between 1982 and 2015) to treat hyperglycemia in both type 1 and type 2 diabetes mellitus”. From these, we looked at the drugs that were listed as treating both types of diabetes (1 and 2) in either or both adults and children, in the hopes that this would indicate more than one release/approval for the drug. This was not effective as none of these drugs appeared to have more than one FDA approval and/or release date. A deeper look in the FDA’s website turned up the entire list of all FDA-approved medicines used to treat diabetes (listed here), along with their approval dates – which clearly shows that each of the drugs has only had one approval / release date. Within the scope of the 10-years for this request (2008 – 2018), there have one 31 drugs approved for treating these diseases in the US. Of these, each has had one approval/release, along with the release of a generic (cheaper) drug. So, unfortunately, none of the drugs fit your criteria.

MEDICATIONS USED FOR TREATING CARDIOVASCULAR CONDITIONS notes that there are “many different classes of drugs that fall under the general term cardiovascular agent”. Our research shows there are 24 different classes of these drugs, several of these classes with multiple subclasses, and all with a list of drugs for treating each one. A review of several of these classes and the drugs within them did not turn up any indication of drugs that have been released for smaller-then-larger populations, nor any that have received more than one FDA approval.


In a search for drugs used to treat liver diseases, our research shows that there are dozens of different types of liver-related illnesses, including those based in alcoholism and those for non-alcoholic issues. These include Autoimmune Hepatitis, Cirrhosis, Hepatitis B, Hepatitis C, liver cancer, and Primary Biliary Cirrhosis, among others. An attempt to scale down the list to find specific drugs to search for led to 1,440 search results on the US Food & Drug Administration website; a deeper search into these results did not turn up any drugs that meet your parameters.


With additional clarifications on specifically what you are searching for, and keeping in mind what we’ve already found to be the case (as noted above), we may be able to find case studies that match what you’re looking for.


Further clarification is needed in order to approach this query from a clear enough standpoint that we will be able to provide relevant case studies.