By: Marcus Hopkins, Blogger
We’ve spoken several times about the new HCV medications making their ways into the marketplace, but what happens when one of these new treatments simply doesn’t pan out for the company that manufactures them?
This question was recently answer, by Boehringer Ingelheim (BI), who, in a statement released on June 18th, have decided not to move forward with any approvals or market considerations for their HCV protease inhibitor, faldaprevir.
BI reached this decision at a key moment in the rapid development of new, easier to tolerate HCV treatments – regimens are switching over to all-oral treatments with fewer side effects and high SVR (cure) rates.
Faldaprevir must be used in conjunction with interferon, making it far more difficult for patients to tolerate (and thus, more likely to either stop or forego treatments, altogether). Additionally, this drug requires a longer length of therapy than the newer regimens (primarily Olysio and Sovaldi), and has a lower SVR rate that these treatments, as well.
Since their June 18th press release, BI has decided to halt any further developments involving faldaprevir, and have withdrawn all pending marketing applications. Furthermore, they have gone further to say that they will most likely not be reentering this field, and will be moving forward by refocusing their efforts on numerous promising development projects in immunology, cardiovascular, respiratory, metabolic diseases, diseases of the central nervous system and oncology.
One of the things that’s interesting about this development is that it has not really sent any ripples throughout the HCV community. Granted, there is some disappointment that patients will now have fewer options when choose a treatment regimen, but, to what degree, honestly, will that make a difference?
This is a question I get a lot – “How does this affect me?”
The people who will take the biggest hit from BI’s withdrawal from the HCV field are those whose incomes relied on Boehringer Ingelheim for some portion of their funding in order to meet the needs of their patients, inform medical professionals of new developments, and/or provide information to educators who will pass on this information to patients and medical professionals.
But, for most patients, will the BI departure really matter to current and future HCV patients? Likely not. The new regimens out on the market, today, are far easier to tolerate, have a higher cure rate, and a shorter length of treatment, all of which bode well for the patients.
In this case, BI seems to have made a smart decision, both for patients and for their bottom line. Mind you, it’s a little disheartening to see that they’ve virtually cut themselves out of this burgeoning market, altogether, by completely shutting down all HCV development, which I must say is a bit surprising – most companies would reassess their product’s viability, and if it’s not up to snuff, work on a new product that will address the issues posed by the initial output.
This process, however, is a very costly, and often unsuccessful venture. In the meantime, we, here at HEAL Blog, look forward to the new developments in the HCV arena, and wish BI the best in their refocused efforts.
Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.