Novartis secures regulatory 'fast pass' in US OK for tropical disease drug
- Swiss pharma Novartis has won the first Food and Drug Administration approval for a treatment for fascioliasis, an infectious disease caused by parasitic flatworms that's also known as liver fluke infestation.
- As part of the approval, the FDA awarded Novartis a priority review voucher (PRV), which the drugmaker can use to speed regulatory review for another medicine in the future, or sell to another company. The agency gives out the vouchers to reward companies for developing treatments for tropical or rare pediatric diseases.
- Although the U.S. is not considered an area of high transmission, the FDA's approval of Egaten should help the medicine clear licensing and importation hurdles in other countries, Novartis said in a Feb. 13 statement.
Tropical disease drug development is not considered a particularly lucrative field for pharma companies — partly the reason why the FDA rewards companies with a PRV for successfully advancing a treatment through to approval.
Receipt of a PRV, then, might be the most valuable part of the FDA's approval for Novartis. Such vouchers can be used to reduce the U.S. review time of a new medicine to about six months from the typical 10 months. For a therapy considered a blockbuster-to-be, that expedited timeline can translate into higher sales and broader market share.
PRVs are also often bought and sold, though prices have come down in recent years as the FDA has awarded more. In November, Eli Lilly bought one for $80 million, a relative bargain compared to the prices PRVs sold for several years ago.
While the FDA has cleared new drugs at an increasing clip, few treatments for topical diseases have secured approval. In recent years, Chemo Research S.L. and Medicines Development for Global Health won U.S. OKs for Chagas disease and river blindness, respectively, picking up PRVs in the process.
Fascioliasis, the disease Egaten (triclabendazole) treats, is considered a neglected tropical disease. Though the World Health Organization estimates at least 2.4 million people around the world are infected, the disease disproportionately affects those living in poor, rural areas. Novartis has been donating Egaten to the WHO for more than a decade and has pledged to continue doing so until 2022.
The WHO supplies Egaten to patients during outbreaks and also works with countries where the disease is endemic. Novartis said its donations have helped treat about 2 million people in more than 30 countries.
Fascioliasis starts when humans ingest flatworm larvae in contaminated food or water. When the larvae mature into worms in the gut, affected individuals can experience significant pain, fever, nausea and diarrhea.
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