FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Sanders, Cummings Request Info on FDA’s Emflaza Approval

March 23, 2017

Two lawmakers have asked the FDA to explain why the agency approved Marathon’s application to market the old drug Emflaza (deflazacort) as a new treatment for Duchenne muscular dystrophy.

In a letter, Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) asked the FDA to provide information on the agency’s decision to award Emflaza an orphan drug designation and grant Marathon a priority review voucher, which have been sold for as much as $350 million.

Emflaza is an internationally used corticosteroid treatment that no longer carries patent protections or market exclusivity in the U.S., but the FDA granted the therapy seven years of exclusivity as an orphan drug, the letter said.

The lawmakers have asked the agency what processes it has in place to ensure drugmakers are not using designations, which are intended to incentivize drug research, to make a profit or dominate a particular market.

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