Calliditas partner STADA receives positive CHMP opinion recommending full approval for Kinpeygo® for the treatment of IgA nephropathy
Calliditas Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Kinpeygo, recommending full marketing authorisation in treating adults with primary immunoglobulin A nephropathy (IgAN). Kinpeygo, which received conditional marketing authorisation in July 2022, now has a broader treatment label, moving from a urine protein excretion limitation of >1.5g/g to ≥0.8g/g. The positive opinion will be forwarded to the European Commission (EC) for final approval, expected in August 2024. STADA Arzneimittel AG will market Kinpeygo in the EU and UK.
- CHMP adopted a positive opinion for Kinpeygo, recommending full marketing authorisation.
- Broader treatment label for Kinpeygo, expanding from UPCR limitation of >1.5g/g to ≥0.8g/g.
- First fully approved medication for IgAN in Europe.
- Long-term confirmatory trial met its eGFR endpoint with high statistical significance.
- Kinpeygo will be marketed in the EU and UK by STADA.
- Final decision by the European Commission is still pending, expected in August 2024.
Insights
The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending full marketing authorization for Kinpeygo is a significant milestone for Calliditas Therapeutics. This development is particularly noteworthy as it transitions the drug from conditional to full marketing authorization, broadening its patient base significantly. The extended approval from a urine protein excretion (UPCR) limitation of > 1.5g/g to encompassing the entire study population (≥ 0.8g/g, or proteinuria of ≥1.0 g/g over 24 hours) substantially increases Kinpeygo’s market potential.
Financially, this broadened approval could lead to increased sales revenues, given the expanded label and potential rise in the number of eligible patients. Investors should pay attention to the impending decision by the European Commission, expected in August 2024, which, if positive, will solidify Kinpeygo’s market positioning in the EU, Iceland, Norway and Liechtenstein.
Additionally, the successful outcome of the long-term confirmatory trial meeting its eGFR endpoint with high statistical significance is a strong validation of the drug’s efficacy. This could translate into heightened investor confidence and potentially lead to a positive performance in Calliditas' stock.
From a medical research perspective, the full approval recommendation for Kinpeygo marks a pivotal advancement in the treatment of IgA nephropathy (IgAN). IgAN is a rare kidney disease that has limited treatment options and Kinpeygo being the first fully approved medication in the EU and UK highlights its therapeutic importance. The expansion of the drug's indications to include a broader spectrum of patients significantly improves its clinical applicability.
Additionally, the confirmatory trial's success in achieving its eGFR endpoint with high statistical significance underscores the drug’s efficacy and safety profile. The eGFR (estimated glomerular filtration rate) is a critical marker of kidney function and meeting this endpoint suggests that Kinpeygo can effectively slow disease progression and improve patient outcomes.
This broader label and robust clinical data not only enhance the drug’s marketability but also position it as a cornerstone therapy for IgAN, encouraging further adoption by healthcare providers.
The expanded approval for Kinpeygo in treating IgA nephropathy is likely to have significant market implications. Given that this disease has had limited treatment options, the full marketing authorization could lead to a competitive edge for Calliditas Therapeutics in the nephrology market. It is expected that STADA Arzneimittel AG, their commercial partner in the EU and UK, will capitalize on this broadened label to increase market penetration and patient reach.
Moreover, the positive opinion from the CHMP signals robust regulatory support, which can enhance the drug’s reputation among healthcare providers and patients. For investors, this can be seen as a strong indicator of future growth potential and market expansion. The timing of the European Commission's final decision will be crucial; a favorable outcome could catalyze further stock appreciation and strategic positioning in the European market.
Kinpeygo, which was granted conditional marketing authorisation in EU on 15 July 2022, was the first ever approved treatment for IgAN in the EU and
"This is an important day for patients suffering from IgAN in
The CHMP's positive opinion will now be forwarded to the European Commission (EC), which has the authority to grant this full marketing authorisation for Kinpeygo in the European Union (EU) member states, and which will be adopted by
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 report 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 person set out above, on May 30, 2024, at 8:00 p.m. CET.
About Calliditas
Calliditas Therapeutics is a biopharma company headquartered in
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas' strategy, commercialization efforts, business plans, regulatory submissions, clinical development plans, revenue and product sales projections or forecasts and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas' business, operations, EC authorization for full approval of Kinpeygo, continued and additional regulatory approvals for TARPEYO and Kinpeygo, market acceptance of TARPEYO and Kinpeygo, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, revenue and product sales projections or forecasts and other risks identified in the section entitled "Risk Factors" in Calliditas' reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
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FAQ
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