STOCKHOLM, March 6,
2024 /PRNewswire/ -- Calliditas Therapeutics
AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas')
today announced that the FDA has granted an orphan drug exclusivity
period of seven years for TARPEYO®, expiring in December 2030 based on when the company obtained
full approval with a new indication for this drug product.
Following full approval in December
2023, TARPEYO® (budesonide) is indicated 'to reduce
the loss of kidney function in adults with primary immunoglobulin A
nephropathy (IgAN) who are at risk for disease progression'. The
exclusivity period reflects the new indication covering all adult
patients with primary IgAN at risk of disease progression based on
a confirmed reduction of kidney loss reflecting a clinical benefit
on kidney function for adult patients with primary IgAN.
"We are delighted to have seven years of market exclusivity
expiring in December 2030 for TARPEYO
in the US, reflecting the new indication based on the long-term
data generated," said CEO Renée Aguiar-Lucander.
CONTACT:
For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com
The information in the press release is information that
Calliditas is obliged to make public pursuant to the EU Market
Abuse Regulation. The information was sent for publication, through
the agency of the contact persons set out above, on March 6, 2024 at 08:15
a.m. CET.
The following files are available for download:
https://mb.cision.com/Main/16574/3941407/2650472.pdf
|
FDA ODEP_EN
|
View original
content:https://www.prnewswire.com/news-releases/calliditas-announces-an-additional-seven-year-orphan-drug-exclusivity-period-for-tarpeyo-302081084.html
SOURCE Calliditas Therapeutics