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Lily's orphan drug 'Jaypirca' receives conditional approval

By Lee, Hye-Kyung | translator Kang, Shin-Kook

24.08.30 05:02:41

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The Central Pharmacist Review Committee decided on conditional approval requiring the submission of Phase 3 study results

Clinical trials showing therapeutic confirmation are expected to be reported by March 2027

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'Jaypirca,' a designated orphan drug for the treatment of Mantle Cell Lymphoma that recently received marketing authorization in South Korea, is expected to submit the Phase 3 trial results showing therapeutic confirmation by March 2027.

As it received conditional approval based on Phase ¨ö clinical trial results, the company must compare Jaypirca to existing Bruton tyrosine kinase (BTK) inhibitors and confirm clinical benefits.

According to the meeting notes of the Central Pharmacist Review Committee, disclosed by the Ministry of Food and Drug Safety (MFDS) on August 27th, the committee members exchanged opinions on conditional approval of Jaypirca, an orphan drug for treating Mantle C

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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