Calliditas Receives Conditional Marketing Authorization from UK MHRA for Kinpeygo in IgA nephropathy

by Lindsey Francy Feb 2, 2023 News
Calliditas Receives Conditional Marketing Authorization from UK MHRA for Kinpeygo in IgA nephropathy

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The Medicines and healthcare products Regulatory Agency of the United Kingdom has granted Conditional approval to Calliditas' product.

Kinpeygo is the only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidneys with a high unmet need, with more than 50% of patients potentially progressing to end-stagerenal disease. STADA Arzneimittel AG is commercializing Kinpeygo in the European Economic Area states of Switzerland and the United Kingdom. Kinpeygo was launched in Germany.

"We are happy to be able to add another approval in a European territory, which will lead to patient access to Kinpeygo, a drug developed specifically to target this disease," said CEO Renée.

Please contact us if you need further information.

Marie Galay works for Calliditas.


The information was sent for publication by the contact persons set out above. The time isCET.

Calliditas has something to say about it.

Calliditas is a biopharma company based in Sweden that is focused on identifying, developing and commercializing novel treatments in orphan indications. Calliditas' lead product, developed under the name Nefecon, has been granted accelerated approval by the FDA and the European Commission. The European Union Member States and the UK are where KINPEY GO will be sold. Calliditas' common shares are listed on the stock exchange in Sweden and its American Depositary shares are listed on the stock exchange in the US.

There are forward-looking statements.

The Private Securities Litigation Reform Act of 1995 includes statements regarding regulatory approval and marketing of Kinpeygo in the UK. The words "may", "could", "would", "should", "expect", "plan", "anticipate", "believe", "estimate", "predict", "project", "potential", "continue", "target", 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 could cause actual events or results to differ from those expressed or implied by any forward-looking statements contained in this press release Calliditas cautions against placing too much reliance on any forward-looking statements which speak only as of the day they are made. Calliditas does not have 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 Calliditas' views are only as of the date hereof, and should not be relied upon as representing its views as of any later date.

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The UK Kinpeygo approval was granted.

Calliditas received marketing authorization from the UK forkinpeygo-in-iga-nephropathy.

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