Knight Therapeutics Receives FDA Approval for Impavido to Treat Leishmaniasis

Knight Therapeutics Inc. has secured approval from the U.S. Food and Drug Administration (FDA) for its drug Impavido® (miltefosine).

The medication is now approved for patients suffering from visceral, mucosal, and cutaneous leishmaniasis. Leishmaniasis is a parasitic disease transmitted by sandflies, with the World Health Organization (WHO) estimating hundreds of thousands of new cases annually worldwide, particularly of the visceral form.

Concurrent with the drug approval, Knight Therapeutics also received a Priority Review Voucher (PRV). This voucher provides an expedited FDA review for any new drug application and is transferable or sellable.

Knight Therapeutics President and CEO Jonathan Ross Goodman stated the company's intention to commercialize Impavido in the United States while also monetizing the voucher. The company is the fourth entity globally to receive such a voucher.

Impavido (miltefosine) is an oral medication with demonstrated activity against Leishmania species and is listed on the WHO's list of essential medicines.