FDA Approves Egaten (triclabendazole) for the Treatment of Fascioliasis, a Neglected Tropical Disease

Novartis announced that the US Food and Drug Administration (FDA) has approved Egaten (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. This makes Egaten the only FDA-approved drug for people with this disease and is expected to facilitate broader access to this important drug not only in the US, but also in affected countries worldwide.

"Novartis has a long-standing commitment to addressing global health challenges and supporting disease elimination efforts, in diseases such as leprosy, malaria and fascioliasis," said Vas Narasimhan, CEO of Novartis. "Today's FDA approval of Egaten is another important milestone that we believe will help further expand access to this one-day treatment, taking us a step closer toward disease elimination."

Fascioliasis, commonly known as liver fluke infestation, is a neglected tropical disease that infects 2.4 million people worldwide[1], with an additional 180 million at risk of infection[2]. It is caused by two species of parasitic flatworms that can infect humans following ingestion of larvae in contaminated water or food.

Egaten is currently the only medicine for fascioliasis recommended by the WHO and is on the WHO Model List of Essential Medicines. It is supplied by WHO during epidemic outbreaks and for periodic use in endemic countries. FDA approval of Egaten is expected to facilitate drug licensing and import to these countries, helping ensure sufficient and prompt availability of the drug when needed. Fascioliasis is recognized by the FDA as a neglected tropical disease, triggering the award of a Priority Review Voucher based upon this approval.

Novartis has been donating Egaten to the WHO since 2005, helping to treat around 2 million fascioliasis patients in more than 30 countries. In 2018, we renewed our agreement with the WHO to extend the drug donation until 2022, expected to reach 300 000 patients per year.

"This FDA decision is welcome news for millions who suffer or are at risk of fascioliasis and removes a major hurdle in expanding treatment to countries where it is most needed," said Dr Mwelecela Malecela, Director of the Department of Control of Neglected Tropical Diseases at the WHO. "We are thankful to Novartis for their sustained decade-long commitment in tackling yet another disease of poverty."

https://en.wikipedia.org/wiki/Triclabendazole

Achaogen Announces FDA Advisory Committee Voted Unanimously in Favor of Plazomicin for Treatment of Adults with Complicated Urinary Tract Infections

Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, announced that the U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee voted on the two points for Advisory Committee consideration as follows:

1. Has the applicant provided substantial evidence of the safety and effectiveness of plazomicin for the treatment of complicated urinary tract infections?

Result: (15-0-0) There were 15 yes votes and zero no votes. No members of the panel abstained.

2. Has the applicant provided substantial evidence of the safety and effectiveness of plazomicin for the treatment of bloodstream infections in patients with limited or no treatment options?

Result: (4-11-0) There were four yes votes and 11 no votes. No members of the panel abstained.

There were 16 panel members at the meeting, one of whom departed prior to the vote and was therefore not present for the voting.

"We are encouraged by the Committee's unanimous vote in favor of plazomicin for complicated urinary tract infections (cUTI). The discussion underscored the real-world challenges that healthcare providers face every day given limited or inadequate treatment options for certain pathogens," said Blake Wise, Achaogen's Chief Executive Officer. "Regarding bloodstream infections, the Limited-Population Antibacterial Drug pathway, or LPAD, is a novel approach that enables the FDA to consider the benefits and risks for the sickest patients who have few or no available treatment options, and to approve antibiotics like plazomicin that we believe, have the potential to address these limited patient populations."

The FDA is not bound by the Committee's votes but takes its input into consideration when reviewing marketing applications. Plazomicin has a Prescription Drug User Fee Act (PDUFA) date of June 25, 2018. If the FDA approves plazomicin by this target action date, Achaogen expects to launch plazomicin in the U.S. soon thereafter.

http://investors.achaogen.com/releasedetail.cfm?ReleaseID=1066053