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news.The Institute for OneWorld Health, the first nonprofit pharmaceutical company in the US, has received orphan drug designation from the FDA and the EMEA, for paromomycin to treat visceral leishmaniasis.
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Visceral leishmaniasis (VL), also known as kala azar (“black fever”), is a fatal disease transmitted by sand flies, which spread leishmania parasites that attack internal organs.
The US Orphan Drug Act provides for formal protocol assistance when requested by the sponsors of drugs for rare diseases or conditions. The EMEA regulations are similar, and have the added advantage of applying to all 25 members of the European Union. Orphan drug designation also provides incentives such as exemption from certain registration fees, and may help pave the way for approvals in other countries.
OneWorld Health will file for approval of paromomycin in India this year where the need is greatest. It will begin the drug approval process with the FDA and/or the EMEA next year.
Paromomycin is an off-patent aminoglycoside antibiotic first used in the 1960s and is still marketed in the US as an oral formulation to treat intestinal parasites. The largest-ever phase III clinical trial for visceral leishmaniasis was completed in November 2004 by OneWorld Health in collaboration with the Special Programme for Research and Training in Tropical Diseases of the World Health Organization (WHO/TDR). The clinical trial used the injectable form of paromomycin in 667 patients in India.