Not The Next Avastin? Plan For New ProAmatine Studies Would Negate Shire’s Withdrawal Hearing Request
A joint proposal from CDER and Shire calling for two new studies to verify clinical benefit of the hypotension agent would negate the need for a hearing on CDER’s proposed withdrawal, if Commissioner Hamburg accepts it.
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CEO William Heiden reaffirms commitment to preterm birth drug and suggests AMAG would seek a hearing under the accelerated approval regulations if the US FDA were to request withdrawal; another placebo-controlled confirmatory trial may be possible in European and South American countries, company says.
The orthostatic hypotension treatment midodrine has been on the market for more than 20 years despite the failure of postmarketing studies to confirm clinical benefit; an advisory committee soon will weigh the future of AMAG’s preterm birth drug Makena, which failed its confirmatory trial required as a condition of accelerated approval.
Northera was approved by FDA under the Subpart H accelerated approval pathway; the Indications and Usage section of the drug’s labeling notes the lack of efficacy data for treatment with the drug beyond two weeks.