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
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