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March 29, 2012 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, reaffirms its commitment to patients as set forth in its recent agreement with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) to conduct two additional clinical trials to verify and describe the clinical benefit of midodrine HCI.
Midodrine HCl, approved in 1996 under Subpart H (an accelerated approval process) for the treatment of symptomatic orthostatic hypotension (SOH), will remain available to patients who rely on this medicine while Shire's trials are conducted.
To read the Midodrine Update from FDA please see the FDA website. Currently there are no alternative FDA-approved treatments for SOH.
"Our agreement with the FDA on clinical trials protocols to confirm the clinical benefit of midodrine is a good outcome and in the best interest of patients who rely on this medicine to manage their SOH symptoms," said
Jeffrey Jonas, M.D., Senior Vice President of Research & Development for Shire. "Our agreement is especially important in light of the recent FDA Complete Response Letter for the New Drug Application (NDA) for droxidopa, a competitor investigational product, for the treatment of symptomatic neurogenic orthostatic hypotension in certain patient types. We appreciate the FDA's agreement to keep midodrine HCI on the market while we conduct the agreed upon trials."
Shire is the NDA holder for midodrine HCl, which had been marketed by Shire until 2010 under the brand name ProAmatine®. Shire has no financial interest in midodrine, and no longer manufactures, distributes or markets the brand name version of midodrine HCI, ProAmatine. Beginning in 2003, midodrine has been manufactured and distributed by generic pharmaceutical companies. As the NDA holder, Shire has continued to invest in the needed regulatory processes and has worked diligently with the FDA to develop this now agreed path forward that may permit midodrine to maintain its marketing authorization thus allowing it to remain available for patients who critically need this medicine.