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Orphan Drugs: FDA Approval For Tropical Disease

March 19, 2014

The FDA announces on March 19th the approval of Impavido (Miltefosine), an oral medicine for the treatment of the tropical disease Leishmaniasis. Leishmaniasis is caused by a parasite, Leishmania, which is transmitted by sand fly bites to humans. It occurs mainly in people who live in the tropics and subtropics. The drug is already approved for sale in Europe, the Indian subcontinent, and Central and South America.

The FDA granted Impavido Fast Track Designation, Priority Review, and Orphan Drug Designation (ODD) (October 2006). Paladin Therapeutics, Impavido’s manufacturer, is awarded a FDA Tropical Disease Priority Review Voucher. This type of Priority Review Voucher (PRV) is awarded under a provision in the FDA Amendments Act of 2007 that encourages the development of new drugs and vaccines for neglected tropical diseases. “The PRV is transferable and can be sold and entitles the bearer to a priority review for any product. To date, only 3 companies have received a PRV and none have been sold.”

The FDA approves Impavido on the orphan drug’s scheduled PDUFA date :

Generic Name TradeName Sponsor Indication 2014 PDUFA  Date
Miltefosine     *** Impavido Paladin Therapeutics Leishmaniasis 03/19

*** NDA

Please note the links for the following 2 chart columns above :

1) “Generic Name” Column Link = Is a source for the FDA PDUFA Date

2) “Indication” Column Link = Is the FDA Orphan Drug Product Designation Database Link.

Please Note: “Phlebotomus Pappatasi Bloodmeal begin” by CDC/ Frank Collins. Photo credit: James Gathany [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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