Shire plc (SHPGY: Quote,SHP.L) said that it reaffirmed its commitment to patients as set forth in its recent agreement with the Center for Drug Evaluation and Research or 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.
"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," said Jeffrey Jonas, M.D., Senior Vice President of Research & Development for Shire.
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