| 2 min read
Register for free to listen to this article
Listen with Speechify
0:00
2:00
INGELHEIM, Germany—June 20 saw Boehringer Ingelheim announce that it has re-evaluated its hepatitis C (HCV) strategy in and “decided not to move forward in this therapeutic area.”
 
As the company notes, “the HCV treatment environment has significantly and rapidly evolved since the submission of the faldaprevir marketing applications to regulatory bodies around the world. There are now several new treatment options available for patients and additional all-oral options are expected to be approved in 2014.”
 
From Boehringer Ingelheim’s perspective, there is no longer an unmet medical need for the faldaprevir interferon-based regimen that was the subject of the application and therefore pursuing it was not longer a useful endeavor.
 
Boehringer Ingelheim noted that it would withdraw all pending marketing applications for faldaprevir worldwide and discontinuing further development.
 
However, Boehringer Ingelheim emphasizes that it is committed to developing new treatments that provide high therapeutic value in areas where medical need exists, and it is focusing its efforts on numerous development projects in immunology, cardiovascular, respiratory, metabolic diseases, diseases of the central nervous system and oncology.
 
One of the biggest reasons for this decision to abandon faldaprevir has to be the HCV treatment success of Gilead Sciences, which offers the NS5B polymerase inhibitor sofosbuvir under the brand name Sovaldi. That HCV therapy was approved in the United States in December 2013 and in Europe earlier this year, making a splash as the biggest pharmaceutical product launch of all time. Sales were around $2.3 billion in just the first quarter of this year.
 
In February, Gilead filed for U.S. approval of an all-oral HCV regimen based on Sovaldi and the NS5A inhibitor ledipasvir and might get a decision from the U.S. Food and Drug Administration on that by fall. AbbVie is seeking approval for its own combination therapy this year as well, and other players with late-stage HCV prospects include Bristol-Myers Squibb, Merck & Co. and Johnson & Johnson, making for a crowded field—and putting an interferon-based regimen like Boehringer Ingelheim’s at a serious disadvantage.

About the Author

Related Topics

Loading Next Article...
Loading Next Article...
Subscribe to Newsletter

Subscribe to our eNewsletters

Stay connected with all of the latest from Drug Discovery News.

Subscribe

Sponsored

Clear sample tubes are shown in a clear tote with red lids in a sample prep robot with a blue and silver industrial lab background.

The crucial role of sample preparation in biotherapy manufacturing

Discover how better sample preparation can unlock improved assay accuracy and analytical results.
A black mosquito is shown on pink human skin against a blurred green backdrop.

Discovering deeper insights into malaria research

Malaria continues to drive urgent research worldwide, with new therapies and tools emerging to combat the parasite’s complex lifecycle and global burden.
Three burgundy round and linear conformations of oligonucleotides are shown against a black background.

Accelerating RNA therapeutic testing with liver microphysiological platforms

Researchers can now study oligonucleotide delivery and efficacy in a system that models a real human liver.
Drug Discovery News March 2025 Issue
Latest IssueVolume 21 • Issue 1 • March 2025

March 2025

March 2025 Issue

Explore this issue