STOCKHOLM, Dec. 23, 2021 /PRNewswire/ -- The Medical
Products Agency in Sweden has
agreed to be reference member state for Moberg Pharma AB's
registration application for MOB-015 (nail fungus treatment). The
company will submit the registration application in Europe through the decentralized process, and
market approval is expected in 2023.
Moberg Pharma will submit a full application, which offers the
possibility of data exclusivity in Europe for up to 10 years following market
approval. Moberg Pharma has been ready to submit the registration
application as soon as the authority can receive it. Due to limited
resources and many parallel ongoing applications, the Swedish
Medical Products Agency has now announced that the application can
be submitted in March 2022. The
company's goal remains unchanged, to receive its first market
approval and launch MOB-015 in 2023.
"We are advancing toward the company's goal to
register a new and improved nail fungus drug. The need for a
treatment alternative that can truly cure the nail infection is
great, which means that MOB-015 can achieve a unique position
through its high antifungal effect," says Anna Ljung, CEO of Moberg Pharma AB.
CONTACT:
For additional information, please contact:
Anna Ljung, CEO, telephone:
+46 707 66 60 30, e-mail: anna.ljung@mobergpharma.se
About this information
This information is information that Moberg Pharma AB is obliged to
make public pursuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of
the contact persons set out above, at 8.00
a.m. CET on December 23,
2021.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/moberg-pharma/r/the-medical-products-agency-in-sweden-will-be-reference-member-state-for-moberg-pharma-s-european-re,c3477705
The following files are available for download:
https://mb.cision.com/Main/1662/3477705/1514041.pdf
|
The Medical Products
Agency in Sweden will be reference member state for Moberg
Pharma’s European registration application
|
View original
content:https://www.prnewswire.com/news-releases/the-medical-products-agency-in-sweden-will-be-reference-member-state-for-moberg-pharmas-european-registration-application-301450288.html
SOURCE Moberg Pharma