lunielucy
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If any of you have this issue with your lupus, and live in the area, heres something you should check out. Maybe they will give vouchers for product discounts. Meds are super spendy these days, just like gas! Rockville, MD, May 9, 2008 - In order for new treatments to be available for ITP they need to be approved by the Food and Drug Administration (FDA). Many of you know about the clinical trials for the new thrombopoietin (TPO)-like treatments that prompt the bone marrow to make more platelets. In the last few months two companies that make these treatments have submitted paperwork to the FDA to seek their approval. The first FDA meeting on one of these treatments, NPlate, was held on March 12. The FDA has now announced a second meeting. This one is to provide input on the approval of Promacta (eltrombopag), a pill developed by GlaxoSmithKline (GSK). In addition to input from GSK and the FDA advisory panel, the FDA is soliciting comments from the public. The meeting will be held on May 30, 2008, from 8 a.m. to 12:30 p.m. at the Hyatt Regency McCormick Place, Regency Ballroom, 2233 South Martin L. King Dr. ,Chicago, IL. The contact person to submit written or oral comments is Nicole Vesely, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-6793, fax: 301-827-6776, e-mail: nicole.vesely@fda.hhs.gov. Written submissions may be made to Ms. Vesely on or before May 21, 2008. Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11:30 a.m. Those desiring to make formal oral presentations should notify Ms. Vesely and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 15, 2008. While I will be at the meeting representing PDSA, as a policy our organization does not take a formal position on the approval of any specific treatment. However, we encourage individuals to share any thoughts/experiences they may have about Promacta. Below is the meeting and contact detail provided by the FDA. If you have input you would like to provide to PDSA, if you will be attending the meeting, or if you will be sending your comments to the FDA, please contact us at pdsa@pdsa.org or toll free (877) 528-3538. You can search on Promacta or eltrombopag for more information about this drug and for clinical trial results. Thank you for your input. Joan Young |
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