Zealand Pharma Announces Boehringer’s U.S. FDA Breakthrough Therapy Designation for Survodutide
Company Announcement – No. 47 / 2024
Breakthrough Therapy Designation and Phase III Trials
Zealand Pharma has announced that Boehringer has received U.S. FDA Breakthrough Therapy designation and has initiated two Phase III trials for survodutide. This designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis, based on survodutide’s groundbreaking results from the Phase II study.
Boehringer has launched two Phase III studies for survodutide: LIVERAGE for adults with MASH and moderate or advanced fibrosis (stages 2 or 3), and LIVERAGE-Cirrhosis for those with MASH and cirrhosis (stage 4).
Copenhagen, Denmark – October 8, 2024
Zealand Pharma A/S (Nasdaq: ZEAL) has made this announcement today in Copenhagen, Denmark.
Impact on You
As a potential patient with MASH and moderate or advanced fibrosis, the breakthrough therapy designation and Phase III trials for survodutide could mean access to a promising new treatment option. It is important to stay updated on the progress of these trials and discuss with your healthcare provider if this medication could be a suitable option for you.
Impact on the World
The U.S. FDA Breakthrough Therapy designation for survodutide and the initiation of two Phase III trials by Boehringer represent significant progress in the field of MASH treatment. If successful, this medication could potentially help improve the outcomes for patients with this condition on a global scale, addressing an unmet medical need in the healthcare community.
Conclusion
In conclusion, the announcement of Boehringer’s U.S. FDA Breakthrough Therapy designation for survodutide by Zealand Pharma marks a significant milestone in the treatment of MASH. With the initiation of Phase III trials, there is hope for a new treatment option that could potentially benefit patients worldwide. It is a step forward in addressing the challenges faced by individuals with MASH and cirrhosis, and we look forward to the outcomes of these trials.
