Wednesday, November 16, 2011 12:17:40 PM
Incyte: FDA approved Jakafi, the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis. (INCY) 12.67 +0.07 : The safety and effectiveness of Jakafi was evaluated in two clinical trials with 528 patients. Patients in both trials were resistant or refractory to available myelofibrosis therapy or ineligible for allogeneic bone marrow transplantation. All patients had enlarged spleens and were in need of treatment as a result of disease-related symptoms. The treatment is being approved ahead of the drug's Dec. 3, 2011 review goal date under the Prescription Drug User Fee Act and has been designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the U.S.
Recent INCY News
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/16/2024 05:25:13 PM
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- Incyte und Syndax melden FDA-Zulassung von Niktimvo™ (Axatilimab-csfr) zur Behandlung der chronischen Graft-versus-Host-Krankheit (GvHD) • Business Wire • 08/15/2024 08:15:00 PM
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- Incyte and Syndax Announce U.S. FDA Approval of Niktimvo™ (axatilimab-csfr) for the Treatment of Chronic Graft-Versus-Host Disease (GVHD) • Business Wire • 08/14/2024 09:34:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/14/2024 07:37:17 PM
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