Innate Pharma seeks European market access for lacutamab with regulatory designations
1 report, 1 independent
Updated Sep 20
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What happened
Innate Pharma announced that its lacutamab drug received the European Medicines Agency PRIME designation and orphan-drug designations in both the U.S. and Europe. The company is currently seeking market access for the drug in Europe through these channels. The company plans to seek accelerated approval in Sézary syndrome in the second half of 2027, based on existing phase II TELLOMAK data.
From themarketsdaily.com
Why it matters
The designations are part of a strategic partnership with Sobi, which received the exclusive global commercialization rights if the product achieves accelerated approval. The successful trials could pave the way for market entry in Europe.
From themarketsdaily.com
Who's involved
- European Medicines AgencyHighest regulatory authority on medicines in the European Union
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The entities involved
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European Medicines Agency
highest regulatory authority on medicines in the European Union
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