Calliditas announces an additional seven year orphan drug exclusivity period for TARPEYO®
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Insights
The FDA's granting of a seven-year orphan drug exclusivity period to Calliditas Therapeutics for TARPEYO® is a significant milestone for the company. This exclusivity, which prevents other companies from marketing generic versions of TARPEYO® for the same indication, effectively grants Calliditas a temporary monopoly in the U.S. market for treating primary immunoglobulin A nephropathy (IgAN), a rare kidney disease. This is particularly notable given that IgAN can lead to end-stage renal disease and limited treatment options are currently available.
The extended market exclusivity until December 2030 provides Calliditas with a prolonged period to capitalize on their investment in developing TARPEYO® without competition, which could lead to increased revenue streams. It is also a positive signal to investors, as the exclusivity period provides a clearer projection of the potential return on investment. The company's share price may respond favorably to this news, as market exclusivity is a strong driver of pharmaceutical stock valuations.
The orphan drug status is granted to drugs that treat rare diseases affecting fewer than 200,000 people in the U.S. TARPEYO®'s designation as such indicates the unmet medical need in the treatment of IgAN. The drug's ability to reduce the loss of kidney function in adults at risk of disease progression addresses a critical therapeutic gap. The clinical benefit on kidney function for adult patients with primary IgAN, as confirmed by the reduction of kidney loss, underscores the drug's potential impact on patient health outcomes and quality of life.
From a research perspective, the exclusivity period also incentivizes continued investment in orphan drugs, which is crucial for innovation in the treatment of rare diseases. For stakeholders, particularly patients and healthcare providers, the news is reassuring as it ensures continued access to a clinically beneficial treatment without the immediate threat of generic competition.
Orphan drug exclusivity has economic implications for both the healthcare system and patients. While it encourages pharmaceutical companies to invest in treatments for rare diseases by offering a period of market exclusivity, it also means that the drug's price is likely to remain high due to lack of competition. This can impact healthcare costs, especially for a condition like IgAN that requires long-term management.
In the short-term, the exclusivity is beneficial for Calliditas as it secures a stable market share and allows for cost recovery and potential profit maximization. However, in the long-term, the healthcare system and patients would benefit from the introduction of generics, which typically lead to reduced drug prices. It will be important to monitor how the exclusivity period affects access to TARPEYO® for patients, particularly in terms of insurance coverage and out-of-pocket costs.
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.
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SOURCE Calliditas Therapeutics
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