European Commission grants marketing authorization for Kinpeygo
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Calliditas Therapeutics AB announced the European Commission gave conditional marketing authorization for Kinpeygo.
According to a press release, the conditional marketing authorization applies in all member states of the EU, as well as Iceland, Norway and Liechtenstein.
Kinpeygo is designed to treat primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression and who have a urine protein to creatinine ratio of at least 1.5g/gram. The treatment was developed under the name Nefecon.
The European Commission approval follows part A of the NeflgArd pivotal phase 3 study, in which researchers evaluated Kinpeygo 16-mg, once daily, oral dose vs. placebo in patients with primary IgAN. Analyses revealed patients taking 16 mg of Kinpeygo daily showed a significant 31% reduction in proteinuria from baseline vs. 5% in the placebo arm after 9 months of treatment, according to the release.
“We are excited to receive the formal approval of Kinpeygo in the [European Economic Area] EEA as the first and only [European Medicine Agencies] EMA-approved medication for this disease. We look forward to continuing to work with our European partner, Stada, as they prepare for commercialization,” Renée Aguiar-Lucander, CEO of Calliditas, said in the release.
Calliditas plans to transfer the authorization for Kinpeygo to its commercial partner Stada. Arzneimittel AG. Stada intends to launch Kinpeygo in the EEA in the second half of 2022.
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